Study on Low-Intensity Chemotherapy, Ponatinib, and Blinatumomab for Treating Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03147612

Provider View

This clinical trial is exploring a combination of low-intensity chemotherapy, ponatinib, and blinatumomab to treat patients with a specific type of acute lymphoblastic leukemia (ALL) that is either not responding to treatment or has returned.

Patient Parameters

Program Overview

The purpose of this study is to see how well a combination of low-intensity chemotherapy, ponatinib, and blinatumomab works in treating patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia (ALL). These treatments aim to stop cancer cells from growing and spreading by using chemotherapy drugs, immunotherapy, and targeted therapy. The study will also evaluate the safety and effectiveness of this treatment combination.

Description

This study is divided into several phases to evaluate the effectiveness and safety of the treatment combination.

Primary Objectives:

  • To assess how well the combination of ponatinib and blinatumomab with low-intensity chemotherapy works in achieving a complete response in newly diagnosed patients with Philadelphia chromosome-positive ALL.
  • To evaluate the response in patients whose disease has returned or is not responding to treatment.

Secondary Objectives:

  • To evaluate other measures of treatment success, such as survival rates and safety.

Exploratory Objectives:

  • To study the role of specific genetic mutations in treatment outcomes.
  • To investigate how changes in genetic material at diagnosis affect relapse-free survival.
  • To explore the impact of minimal residual disease on relapse-free survival.
  • To examine the effect on immune cells in patients treated with blinatumomab and ponatinib.

Treatment Plan:

  • Cycles 1 and 3: Patients receive ponatinib daily, chemotherapy drugs like cyclophosphamide and vincristine, and immunotherapy drugs like rituximab. Additional medications are given to support the immune system and prevent disease progression.
  • Cycles 2 and 4: Patients continue with ponatinib and receive different chemotherapy drugs like methotrexate and cytarabine, along with rituximab.
  • Cycles 5-8: Patients receive blinatumomab continuously for four weeks every six weeks, along with other supportive treatments.

Maintenance Therapy:

  • Patients continue with cycles of treatment, alternating between blinatumomab and a combination of vincristine, prednisone, and ponatinib, for up to 15 cycles.

Post-Maintenance Therapy:

  • Patients may continue with ponatinib for up to five years if the disease does not progress.

After completing the study treatment, patients will have follow-up visits to monitor their health and treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with newly diagnosed or relapsed Philadelphia chromosome-positive ALL.
  • Patients with a performance status of 2 or lower, indicating they are able to carry out daily activities with some limitations.
  • Adequate liver and kidney function as indicated by specific blood tests.
  • Female patients must not be pregnant and must agree to use effective contraception.
  • Male patients must agree to use effective contraception.
  • Adequate heart function as assessed by a doctor.
  • Signed informed consent to participate in the study.

Exclusion Criteria

  • Active serious infections not controlled by antibiotics.
  • Known active hepatitis B, unless on appropriate treatment.
  • History of pancreatitis or alcohol abuse.
  • Uncontrolled high triglyceride levels.
  • Active secondary cancer that may shorten survival.
  • Severe heart conditions or recent heart attacks.
  • Taking medications that interfere with the study drugs.
  • History of significant central nervous system disorders.
  • Current autoimmune disease affecting the nervous system.
  • Recent treatment with other investigational drugs.
  • Pregnant or breastfeeding women.
  • History of significant bleeding disorders unrelated to cancer.
  • Significant fluid buildup around the lungs or heart.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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