Study on Ibrutinib and Blinatumomab for Treating Patients with Relapsed or Hard-to-Treat B Acute Lymphoblastic Leukemia

Sponsor: Brian Jonas

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02997761

Provider View

This clinical trial is exploring how well the combination of ibrutinib and blinatumomab works in treating patients with B acute lymphoblastic leukemia that has returned or is not responding to treatment. The study aims to see if these drugs can better control the cancer by stopping its growth and spread.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of two drugs, ibrutinib and blinatumomab, in patients with B acute lymphoblastic leukemia (B-ALL) that has come back or is not responding to treatment. Ibrutinib works by blocking certain enzymes that cancer cells need to grow, while blinatumomab is a type of antibody that can interfere with cancer cell growth and spread. The study aims to find out if using these two drugs together can improve treatment outcomes for patients with relapsed or refractory B-ALL.

Description

The main goal of this study is to evaluate how well ibrutinib and blinatumomab work together in treating patients with relapsed or refractory B acute lymphoblastic leukemia (B-ALL) by measuring the complete response rate, which indicates the absence of detectable cancer.

Secondary goals include examining the overall response rate, which includes complete responses and partial responses, as well as relapse-free survival, overall survival, and the response of minimal residual disease. The study will also look at how many patients can proceed to a bone marrow transplant and assess any side effects or toxicities from the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) with measurable cancer in the bone marrow or other sites.
  • Philadelphia chromosome-positive (Ph+) B-ALL patients must have tried at least one second-generation tyrosine kinase inhibitor.
  • Previous bone marrow transplant is allowed.
  • No specific blood count requirements; patients who need blood transfusions are eligible.
  • Liver and kidney function within specified limits.
  • Ability to understand and sign a consent form.
  • Women must not be pregnant and must use effective birth control during and after treatment.
  • Men and women must agree to use effective birth control methods during and after treatment.
  • Patients taking medications that might affect the study drugs will be reviewed by the investigator.

Exclusion Criteria

  • Diagnosis of T acute lymphoblastic leukemia (T-ALL) or Burkitt's leukemia/lymphoma.
  • Active central nervous system (CNS) leukemia.
  • Previous treatment with ibrutinib or blinatumomab.
  • Recent treatment with other cancer therapies or investigational drugs.
  • Recent bone marrow transplant (less than three months ago).
  • Active graft versus host disease (GVHD) greater than grade 1.
  • Allergic reactions to similar drugs.
  • Recent live vaccines.
  • Recent serious infections.
  • Unresolved side effects from previous cancer treatments.
  • Known bleeding disorders or recent stroke.
  • Active infections like HIV, hepatitis B, or hepatitis C.
  • Recent major surgery.
  • Serious medical conditions that could affect safety or study results.
  • History of other cancers unless treated and inactive for at least three years.
  • Use of certain blood thinners or medications that affect the study drugs.
  • Significant liver impairment.
  • Pregnant or breastfeeding women.
  • Participation in other clinical trials.
  • Unable to comply with study requirements or understand the study.

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