Phase 2 Study on the Safety and Effectiveness of Blinatumomab with Low-Intensity Chemotherapy for Older Patients with Newly Diagnosed B-cell Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07153796

Provider View

This clinical trial is testing a new treatment approach using Blinatumomab, given as a shot under the skin, combined with low-intensity chemotherapy for older adults with a specific type of blood cancer called B-cell Acute Lymphoblastic Leukemia (B-ALL).

Patient Parameters

Program Overview

The study aims to find out if combining Blinatumomab with low-intensity chemotherapy is safe and effective for older patients or those who are not fit for intensive treatment, who have been newly diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL) that does not have the Philadelphia chromosome.

Description

The main goal of this study is to see how long patients can live without their cancer coming back or worsening after starting treatment with Blinatumomab and low-intensity chemotherapy. Researchers will also look at how many patients achieve complete remission, how long patients live overall, and how many patients have no detectable cancer cells after treatment. The safety of this treatment combination will also be evaluated. Additionally, researchers will explore the potential for further analysis of single cells and their relation to other blood disorders.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 60 or older with newly diagnosed B-ALL without the Philadelphia chromosome, who may have had minimal prior treatment (up to 2 cycles).
  • Patients aged 18 to 59 with newly diagnosed B-ALL without the Philadelphia chromosome, who are not fit for intensive chemotherapy and may have had minimal prior treatment (up to 2 cycles).
  • Patients considered unfit due to:
    • Severe heart conditions
    • Severe lung conditions
    • Liver issues
  • ECOG performance status of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Adequate organ function, including kidney and liver function within specified limits.
  • Women and men must agree to use effective birth control during the study and for a period after the study to prevent pregnancy.

Exclusion Criteria

  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Previous treatment with Blinatumomab.
  • Patients with B-ALL that has the Philadelphia chromosome.
  • Known HIV-positive patients.
  • Patients with active or uncontrolled hepatitis or other infections.
  • Patients with severe heart issues or low heart function.
  • Patients unable or unwilling to sign the consent form.
  • Recent participation in another clinical trial within the last 14 days.
  • Patients with active or severe brain conditions or diseases.
  • Patients with uncontrolled autoimmune diseases or psychiatric conditions that may affect study participation.

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