RECRUITING

Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia

Conditions

Recurrent B Acute Lymphoblastic Leukemia Recurrent B Lymphoblastic Lymphoma Refractory B Acute Lymphoblastic Leukemia Refractory B Lymphoblastic Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

Official Title

A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Quick Facts

Study Start:2017-06-19

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02981628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must be \>= 1 year and \< 22 years of age at the time of enrollment * Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with \>= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease * NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study * Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing \>= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method * Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin \[PE\] is strongly recommended) * In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1,000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen * Patients with one of the following: * Second or greater relapse; * Primary refractory disease with at least 2 prior induction attempts; * First relapse refractory to at least one prior re-induction attempt * Any relapse after HSCT (Cohort 1 ONLY) * Any of above disease status, OR * First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or prior HSCT are NOT eligible for Cohort 2 combination therapy * Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs) * Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =\< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. Apply to Cohort 2: * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment. * A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and/or methotrexate). * A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment * \>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. For patients who previously received calaspargase pegol, \>= 21 days must have elapsed after the last dose. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy. * Note: Cytoreduction with hydroxyurea must be discontinued \>= 24 hours prior to the start of protocol therapy. * Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): \>= 7 days after the last dose of agent. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment. * Anti-cancer agents that are antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria. * Corticosteroids: If used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction. * Radiotherapy: \>= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); \>= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if \>= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; \>= 6 weeks must have elapsed if other substantial bone marrow irradiation was given. * Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed. * Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed from the last CAR-T cell infusion * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or * A serum creatinine based on age/gender as follows: * 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL (both male and female) * 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL (both male and female) * 6 to \< 10 years: maximum serum creatinine 1 mg/dL (both male and female) * 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL (both male and female) * 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female) * \>= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female) * Direct bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L	* Patients with any prior history of SOS irrespective of severity * Patients with isolated central nervous system (CNS), testicular, or any other extramedullary site of relapse * Patients who have been previously treated with inotuzumab ozogamicin * Patients who have previously received HSCT (Cohort 2 only) * Patients with Down syndrome (Cohort 2 only) * History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study * Note: Patients with history of allergy to pegaspargase/calaspargase pegol are eligible for enrollment on Cohort 2 if Erwinia formulation of asparaginase can be obtained * Patients with active optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement * Patients who are currently receiving another investigational drug * Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy) * Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD or anti-rejection medications * Patients who are currently receiving or plan to receive corticosteroids except as described below * Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, (Cohort 1 only) for all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications * Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient * Patients who have an active uncontrolled infection defined as: * Positive bacterial blood culture within 48 hours of study enrollment; * Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection * Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline * Active viral or protozoal infection requiring IV treatment * Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Schwachman (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome * There have been no human studies of inotuzumab ozogamicin in pregnant women and no reports of exposure in utero; based on nonclinical safety studies, inotuzumab ozogamicin has the potential to impair human male and female fertility and to adversely affect human embryo fetal development; women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin; there is no information regarding the presence of inotuzumab ozogamicin in human milk, the effects on the breast-fed infant, or the effects on milk production; because of the potential for adverse reactions in breast-fed infants, women should not breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months after the final dose * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment * Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of inotuzumab ozogamicin * Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and for at least 5 months after the last dose of inotuzumab ozogamicin * Lactating females are not eligible unless they agree not to breastfeed their infants

Inclusion Criteria

Exclusion Criteria

* Patients must be \>= 1 year and \< 22 years of age at the time of enrollment
* Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with \>= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
* NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study
* Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing \>= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method
* Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin \[PE\] is strongly recommended)
* In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1,000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
* Patients with one of the following:
* Second or greater relapse;
* Primary refractory disease with at least 2 prior induction attempts;
* First relapse refractory to at least one prior re-induction attempt
* Any relapse after HSCT (Cohort 1 ONLY)
* Any of above disease status, OR
* First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or prior HSCT are NOT eligible for Cohort 2 combination therapy
* Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)
* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =\< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. Apply to Cohort 2:
* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.
* A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and/or methotrexate).
* A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment
* \>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. For patients who previously received calaspargase pegol, \>= 21 days must have elapsed after the last dose. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy.
* Note: Cytoreduction with hydroxyurea must be discontinued \>= 24 hours prior to the start of protocol therapy.
* Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): \>= 7 days after the last dose of agent. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment.
* Anti-cancer agents that are antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria.
* Corticosteroids: If used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction.
* Radiotherapy: \>= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); \>= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if \>= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; \>= 6 weeks must have elapsed if other substantial bone marrow irradiation was given.
* Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed.
* Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed from the last CAR-T cell infusion
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or
* A serum creatinine based on age/gender as follows:
* 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
* 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
* 6 to \< 10 years: maximum serum creatinine 1 mg/dL (both male and female)
* 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
* 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
* \>= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
* Direct bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L

* Patients with any prior history of SOS irrespective of severity
* Patients with isolated central nervous system (CNS), testicular, or any other extramedullary site of relapse
* Patients who have been previously treated with inotuzumab ozogamicin
* Patients who have previously received HSCT (Cohort 2 only)
* Patients with Down syndrome (Cohort 2 only)
* History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study
* Note: Patients with history of allergy to pegaspargase/calaspargase pegol are eligible for enrollment on Cohort 2 if Erwinia formulation of asparaginase can be obtained
* Patients with active optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement
* Patients who are currently receiving another investigational drug
* Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy)
* Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD or anti-rejection medications
* Patients who are currently receiving or plan to receive corticosteroids except as described below
* Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, (Cohort 1 only) for all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications
* Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient
* Patients who have an active uncontrolled infection defined as:
* Positive bacterial blood culture within 48 hours of study enrollment;
* Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability
* A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
* Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline
* Active viral or protozoal infection requiring IV treatment
* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Schwachman (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome
* There have been no human studies of inotuzumab ozogamicin in pregnant women and no reports of exposure in utero; based on nonclinical safety studies, inotuzumab ozogamicin has the potential to impair human male and female fertility and to adversely affect human embryo fetal development; women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin; there is no information regarding the presence of inotuzumab ozogamicin in human milk, the effects on the breast-fed infant, or the effects on milk production; because of the potential for adverse reactions in breast-fed infants, women should not breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months after the final dose
* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment
* Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of inotuzumab ozogamicin
* Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and for at least 5 months after the last dose of inotuzumab ozogamicin
* Lactating females are not eligible unless they agree not to breastfeed their infants

Contacts and Locations

Principal Investigator

Maureen M O'Brien

PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama

Birmingham, Alabama, 35233

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

Banner Children's at Desert

Mesa, Arizona, 85202

United States

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

United States

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

United States

Kaiser Permanente Downey Medical Center

Downey, California, 90242

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Loma Linda University Medical Center

Loma Linda, California, 92354

United States

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Valley Children's Hospital

Madera, California, 93636

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

United States

Kaiser Permanente-Oakland

Oakland, California, 94611

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

United States

Sutter Medical Center Sacramento

Sacramento, California, 95816

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

United States

Rady Children's Hospital - San Diego

San Diego, California, 92123

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218

United States

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

Yale University

New Haven, Connecticut, 06520

United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

United States

Children's National Medical Center

Washington, District of Columbia, 20010

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

United States

Nicklaus Children's Hospital

Miami, Florida, 33155

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Nemours Children's Hospital

Orlando, Florida, 32827

United States

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607

United States

Saint Mary's Hospital

West Palm Beach, Florida, 33407

United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329

United States

Memorial Health University Medical Center

Savannah, Georgia, 31404

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Riley Hospital for Children

Indianapolis, Indiana, 46202

United States

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

United States

Blank Children's Hospital

Des Moines, Iowa, 50309

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Norton Children's Hospital

Louisville, Kentucky, 40202

United States

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

Eastern Maine Medical Center

Bangor, Maine, 04401

United States

Maine Children's Cancer Program

Scarborough, Maine, 04074

United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Tufts Children's Hospital

Boston, Massachusetts, 02111

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655

United States

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

United States

Michigan State University Clinical Center

East Lansing, Michigan, 48824

United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503

United States

Corewell Health Children's

Royal Oak, Michigan, 48073

United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

University of Missouri Children's Hospital

Columbia, Missouri, 65212

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

United States

Cardinal Glennon Children's Medical Center

Saint Louis, Missouri, 63104

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109

United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

United States

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

United States

Renown Regional Medical Center

Reno, Nevada, 89502

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Morristown Medical Center

Morristown, New Jersey, 07960

United States

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

United States

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903

United States

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

United States

Albany Medical Center

Albany, New York, 12208

United States

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

United States

Maimonides Medical Center

Brooklyn, New York, 11219

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

NYU Langone Hospital - Long Island

Mineola, New York, 11501

United States

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

University of Rochester

Rochester, New York, 14642

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

State University of New York Upstate Medical University

Syracuse, New York, 13210

United States

New York Medical College

Valhalla, New York, 10595

United States

Mission Hospital

Asheville, North Carolina, 28801

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

East Carolina University

Greenville, North Carolina, 27834

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Dayton Children's Hospital

Dayton, Ohio, 45404

United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403

United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

United States

Driscoll Children's Hospital

Corpus Christi, Texas, 78411

United States

Medical City Dallas Hospital

Dallas, Texas, 75230

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

El Paso Children's Hospital

El Paso, Texas, 79905

United States

Cook Children's Medical Center

Fort Worth, Texas, 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

Covenant Children's Hospital

Lubbock, Texas, 79410

United States

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415

United States

Children's Hospital of San Antonio

San Antonio, Texas, 78207

United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Primary Children's Hospital

Salt Lake City, Utah, 84113

United States

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

United States

West Virginia University Healthcare

Morgantown, West Virginia, 26506

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

Maureen M O'Brien, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-06-19

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2017-06-19

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Recurrent B Acute Lymphoblastic Leukemia
Recurrent B Lymphoblastic Lymphoma
Refractory B Acute Lymphoblastic Leukemia
Refractory B Lymphoblastic Lymphoma