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Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia

NCT03263572 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-20

No results posted yet for this study

Summary

This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.

Conditions

  • Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Acute Lymphoblastic Leukemia
  • BCR-ABL1 Fusion Protein Expression
  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Philadelphia Chromosome Positive
  • Recurrent Acute Lymphoblastic Leukemia
  • Refractory Acute Lymphoblastic Leukemia
  • t(9;22)

Interventions

BIOLOGICAL

Blinatumomab

Given IV

DRUG

Cytarabine

Given intrathecally via spinal tap

DRUG

Methotrexate

Given intrathecally via spinal tap

DRUG

Ponatinib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Amgen

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Elias Jabbour · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263572 on ClinicalTrials.gov