RECRUITING

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Conditions

Down Syndrome Recurrent B Acute Lymphoblastic Leukemia

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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 the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

Official Title

A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse

Quick Facts

Study Start:2020-12-17

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04546399

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 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must be \>= 1 and \< 31 years at time of enrollment * Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories: * Isolated bone marrow relapse * Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes * Patients with Down syndrome (DS) are eligible in the following categories: * Isolated bone marrow relapse * Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * 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 * Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression * Patients must not have had a prior hematopoietic stem cell transplant * A single intrathecal chemotherapy at the time of relapse will be allowed. If \< 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted * In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible * Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \>= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required * Patients with Down syndrome who received pre-enrollment therapy and have a WBC \< 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy * Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment): * Age: Maximum serum creatinine (mg/dL) * 1 to \< 2 years: 0.6 (male), 0.6 (female) * 2 to \< 6 years: 0.8 (male), 0.8 (female) * 6 to \< 10 years: 1 (male), 1 (female) * 10 to \< 13 years: 1.2 (male), 1.2 (female) * 13 to \< 16 years: 1.5 (male), 1.4 (female) * \>= 16 years: 1.7 (male), 1.4 (female) * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC) * Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram * No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met	* Patients with B-lymphoblastic lymphoma (B-LLy) * Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia * Patients with Philadelphia chromosome positive (Ph+) B-ALL * Patients with mixed phenotype acute leukemia (MPAL) * Patients with known Charcot-Marie-Tooth disease * Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype * Patients with active, uncontrolled infection defined as: * Positive bacterial blood culture within 48 hours of study enrollment * Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if 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. * Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \> 48 hours * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection * 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, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible. * Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible * Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved * Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * Group 4 and patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible * Note: Group 3 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. 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 this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab * Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose

Inclusion Criteria

Exclusion Criteria

* Patients must be \>= 1 and \< 31 years at time of enrollment
* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:
* Isolated bone marrow relapse
* Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
* Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes
* Patients with Down syndrome (DS) are eligible in the following categories:
* Isolated bone marrow relapse
* Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
* 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
* Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression
* Patients must not have had a prior hematopoietic stem cell transplant
* A single intrathecal chemotherapy at the time of relapse will be allowed. If \< 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted
* In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible
* Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \>= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required
* Patients with Down syndrome who received pre-enrollment therapy and have a WBC \< 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy
* Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment):
* Age: Maximum serum creatinine (mg/dL)
* 1 to \< 2 years: 0.6 (male), 0.6 (female)
* 2 to \< 6 years: 0.8 (male), 0.8 (female)
* 6 to \< 10 years: 1 (male), 1 (female)
* 10 to \< 13 years: 1.2 (male), 1.2 (female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: 1.7 (male), 1.4 (female)
* The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)
* Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

* Patients with B-lymphoblastic lymphoma (B-LLy)
* Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
* Patients with Philadelphia chromosome positive (Ph+) B-ALL
* Patients with mixed phenotype acute leukemia (MPAL)
* Patients with known Charcot-Marie-Tooth disease
* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype
* Patients with active, uncontrolled infection defined as:
* Positive bacterial blood culture within 48 hours of study enrollment
* Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if 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.
* Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \> 48 hours
* A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
* 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, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.
* Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible
* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement
* Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
* Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
* Group 4 and patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible
* Note: Group 3 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease
* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. 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 this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab
* Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose

Contacts and Locations

Principal Investigator

Stacy L Cooper

PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama

Birmingham, Alabama, 35233

United States

USA Health Strada Patient Care Center

Mobile, Alabama, 36604

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

Kingman Regional Medical Center

Kingman, Arizona, 86401

United States

Banner Children's at Desert

Mesa, Arizona, 85202

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-Anaheim

Anaheim, California, 92806

United States

PCR Oncology

Arroyo Grande, California, 93420

United States

Kaiser Permanente-Bellflower

Bellflower, California, 90706

United States

Kaiser Permanente Downey Medical Center

Downey, California, 90242

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Kaiser Permanente-Fontana

Fontana, California, 92335

United States

Loma Linda University Medical Center

Loma Linda, California, 92354

United States

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Mattel Children's Hospital UCLA

Los Angeles, California, 90095

United States

Valley Children's Hospital

Madera, California, 93636

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

Kaiser Permanente-San Diego Zion

San Diego, California, 92120

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

AdventHealth Orlando

Orlando, Florida, 32803

United States

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

United States

Nemours Children's Hospital

Orlando, Florida, 32827

United States

Sacred Heart Hospital

Pensacola, Florida, 32504

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 Medical Center

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 Illinois

Chicago, Illinois, 60612

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

Riley Hospital for Children

Indianapolis, Indiana, 46202

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

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

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

United States

Tufts Children's Hospital

Boston, Massachusetts, 02111

United States

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

United States

Bronson Battle Creek

Battle Creek, Michigan, 49017

United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124

United States

Children's Hospital of Michigan

Detroit, Michigan, 48201

United States

Michigan State University Clinical Center

East Lansing, Michigan, 48824

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

United States

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

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

United States

Ascension Borgess Hospital

Kalamazoo, Michigan, 49048

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

United States

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

United States

Corewell Health Children's

Royal Oak, Michigan, 48073

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

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

University of Mississippi Medical Center

Jackson, Mississippi, 39216

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

Carson Tahoe Regional Medical Center

Carson City, Nevada, 89703

United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052

United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, 89052

United States

Las Vegas Cancer Center-Henderson

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052

United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, 89074

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

United States

Hope Cancer Care of Nevada

Las Vegas, Nevada, 89103

United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109

United States

Ann M Wierman MD LTD

Las Vegas, Nevada, 89128

United States

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128

United States

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, 89128

United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

United States

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, 89144

United States

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144

United States

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

United States

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, 89148-2405

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

United States

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169

United States

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, 89048

United States

Renown Regional Medical Center

Reno, Nevada, 89502

United States

Saint Mary's Regional Medical Center

Reno, Nevada, 89503

United States

Cancer Care Specialists - Reno

Reno, Nevada, 89511

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

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

New Brunswick, New Jersey, 08903

United States

Rutgers Cancer Institute of New Jersey

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

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

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032

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

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

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

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

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 Flower Hospital

Sylvania, Ohio, 43560

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

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

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

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

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

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Overlake Medical Center

Bellevue, Washington, 98004

United States

Valley Medical Center

Renton, Washington, 98055

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

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

United States

Madigan Army Medical Center

Tacoma, Washington, 98431

United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902

United States

United Hospital Center

Bridgeport, West Virginia, 26330

United States

WVUH-Berkely Medical Center

Martinsburg, West Virginia, 25401

United States

West Virginia University Healthcare

Morgantown, West Virginia, 26506

United States

Camden Clark Medical Center

Parkersburg, West Virginia, 26101

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Stacy L Cooper, 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 Date2020-12-17

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2020-12-17

Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

Down Syndrome
Recurrent B Acute Lymphoblastic Leukemia