Study on Mini-Hyper-CVD with Rituximab, Inotuzumab Ozogamicin, and Blinatumomab for Relapsed B-Cell Acute Lymphocytic Leukemia in Children

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05645718

Provider View

This clinical trial is testing a new treatment combination for children and young adults with B-cell acute lymphocytic leukemia (ALL) that has returned or not responded to previous treatments. The study aims to see if this combination can effectively control the disease.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of chemotherapy drugs (cyclophosphamide, vincristine, and dexamethasone) along with other medications (rituximab, blinatumomab, and inotuzumab ozogamicin) can help control B-cell acute lymphocytic leukemia (ALL) in children and young adults whose cancer has come back or not responded to treatment. The treatment is given in a specific sequence and includes chemotherapy delivered directly into the spine.

Description

The main goal of this study is to see how well the combination of mini-hyper-CVD chemotherapy with rituximab, inotuzumab ozogamicin, and blinatumomab works in treating children and young adults with relapsed B-cell acute lymphoblastic leukemia (ALL). Researchers will measure the success of the treatment by looking at how many patients achieve a complete response, meaning no signs of cancer are found.

Secondary goals include evaluating the overall survival of patients, how long they remain free of cancer events, and the safety of the treatment. Researchers will also explore how genetic changes in the leukemia cells relate to the success of the treatment and the possibility of needing a stem cell transplant.

Participants in the study will receive a combination of chemotherapy drugs and other medications in a specific order. The treatment includes drugs given directly into the spine to target cancer cells in the central nervous system. The study will monitor the patients' response to the treatment and any side effects they may experience.

Eligibility Criteria

Inclusion Criteria

  • Children, adolescents, or young adults with B-cell acute lymphocytic leukemia (ALL) that has returned or not responded to treatment.
  • Unable to receive certain chemotherapy drugs or have an intolerance to PEG-asparaginase.
  • Have at least 5% cancer cells in the bone marrow or blood.
  • Can participate even if they do not have the CD20 marker, but will not receive rituximab.
  • Must be in relatively good health, with a performance status score of 50 or higher.
  • Can have asymptomatic central nervous system (CNS) leukemia.
  • Aged between 1 and 25 years old.
  • Must have certain baseline blood test results within specified limits.
  • Females of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified time after treatment.
  • Males must agree to use a condom and not donate sperm during the study and for a specified time after treatment.
  • Patients with certain heart conditions or who have received high doses of specific chemotherapy drugs may still be eligible.

Exclusion Criteria

  • History of another type of cancer, except for certain skin cancers or other solid tumors treated successfully.
  • Uncontrolled central nervous system (CNS) conditions like epilepsy or severe brain injuries.
  • Significant heart disease or arrhythmias requiring medication.
  • Uncontrolled active infections.
  • Active hepatitis B or C infection or HIV.
  • Serious liver disease or alcohol abuse.
  • Active graft-versus-host disease (GvHD) or receiving treatment for GvHD.
  • Not fully recovered from previous cancer treatments.
  • Pregnant or breastfeeding women.
  • Not willing to use effective contraception.
  • Severe medical or psychiatric conditions that may interfere with the study.
  • Patients with Trisomy 21 or bone marrow failure syndromes.
  • Allergic reactions to study drugs.
  • Unable or unwilling to comply with study requirements.
  • Currently participating in another clinical trial.

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