Study on Inotuzumab Ozogamicin for Treating B-cell Acute Lymphocytic Leukemia with Minimal Residual Disease

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03441061

Provider View

This clinical trial is testing how well the drug inotuzumab ozogamicin works in patients with B-cell acute lymphocytic leukemia (ALL) who still have small amounts of cancer cells after treatment. The drug targets and kills specific cancer cells.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of inotuzumab ozogamicin in treating patients with B-cell acute lymphocytic leukemia (ALL) who have minimal residual disease (MRD), meaning small amounts of cancer cells remain after treatment. Inotuzumab ozogamicin is a special type of drug that targets and kills cancer cells by attaching to a specific marker on B cells called CD22.

Description

The main goal of this study is to see how well inotuzumab ozogamicin works in preventing the return of leukemia in patients who are in complete remission but still have minimal residual disease (MRD). Researchers will also look at other outcomes, such as overall survival and the rate at which patients become MRD-negative, meaning no detectable cancer cells, after treatment.

Patients in the study will receive inotuzumab ozogamicin through an IV infusion over one hour on days 1 and 8 of each treatment cycle. Each cycle lasts between 21 to 28 days, and patients can receive up to 6 cycles as long as the disease does not progress and side effects are manageable.

After finishing the treatment, patients will have follow-up visits 30 days later and then every 6 months to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Patients with B-cell acute lymphocytic leukemia (ALL) who are in complete remission but still have minimal residual disease (MRD) after initial treatment.
  • Patients who have had a relapse of MRD after being MRD-negative.
  • Patients with B-cell ALL in complete remission after salvage therapy, including those who had a stem cell transplant.
  • Patients with a specific type of ALL (Ph+ ALL) can join the study in their first or second remission, with additional treatment at the doctor's discretion.
  • Good overall health with a performance status of 0, 1, or 2.
  • Adequate kidney and liver function as shown by specific blood tests.
  • No other active or life-threatening cancers.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Patients who are HIV positive.
  • Patients with uncontrolled infections or diseases.
  • Patients unable or unwilling to provide consent.
  • Patients with active cancer in the central nervous system or other areas outside the bone marrow.
  • Recent treatment with monoclonal antibodies, radiotherapy, or certain cancer drugs within two weeks before starting the study.

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