TERMINATED

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation

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Conditions

Acute Lymphoblastic LeukemiaB Acute Lymphoblastic LeukemiaLymphocytic NeoplasmLymphoma

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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

The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.

Official Title

Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation

Quick Facts

Study Start:2019-10-28
Study Completion:2025-10-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT03856216

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:12 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants age 12 to 75.
  2. * English and non-English speaking participants are eligible.
  3. * CD22+ lymphoid malignancies including B-ALL
  4. * Eligible to receive a reduced-intensity alloSCT
  5. * Indolent lymphoma participants who failed conventional treatment; or,
  6. * Acute lymphoblastic leukemia (ALL), aggressive lymphoma, indolent lymphoma in transformation, or those who have failed ≥ three small molecule inhibitors
  7. * Donor: HLA compatible (8/8 match) related or matched unrelated donor (HLA-A, B, C, DRB1) or mismatched MUD (7/8 match) or haploidentical
  8. * Performance status of 0 to 2, Lansky ≥ 80 for \< 16 years and Karnofsky ≥ 80 for ≥ 16 years of age.
  9. * Adequate organ function at time of study entry
  10. 1. Creatinine less than or equal to 1.6 mg/dL
  11. 2. Bilirubin less than 1.6 mg/dL
  12. 3. SGPT \< 2 x UL
  13. 4. Ejection fraction \>/= 40%
  14. 5. FEV1, FVC and cDLCO \>/= 40%
  15. * Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  1. * Human immunodeficiency virus (HIV) positive.
  2. * Prior autologous transplant less than 1 year prior to consent.
  3. * Active and uncontrolled disease/infection.
  4. * Unable or unwilling to sign consent.
  5. * Current active hepatic or biliary disease (with exception of Gilbert's syndrome).
  6. * Active hepatitis B or C.
  7. * Recent systemic chemotherapy or radiation within 3 weeks of study entry (intrathecal therapy is allowed).
  8. * Prior inotuzumab ozogamicin within 3 weeks of study entry.
  9. * Peripheral blast count of greater than 10 K/mL.
  10. * QTcF interval \> 470 ms.
  11. * Participants with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.

Contacts and Locations

Principal Investigator

Issa F Khouri
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Issa F Khouri, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2019-10-28
Study Completion Date2025-10-13

Study Record Updates

Study Start Date2019-10-28
Study Completion Date2025-10-13

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • B Acute Lymphoblastic Leukemia
  • Lymphocytic Neoplasm
  • Lymphoma