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A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

NCT03589326 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2025-11-26

Study results available
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Summary

In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib.

The main aim of this study is to compare the number of participants on each treatment that show no signs of disease.

Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.

Conditions

  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Interventions

DRUG

Ponatinib

Ponatinib Tablets.

DRUG

Imatinib

Imatinib Tablets.

DRUG

Vincristine

Vincristine IV injection.

DRUG

Dexamethasone

Dexamethasone Tablets.

DRUG

Cytarabine

Cytarabine IV infusion.

DRUG

Methotrexate

Methotrexate IV infusion.

DRUG

Prednisone

Prednisone Tablets.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2022-08-12
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Finland
  • France
  • Greece
  • Italy
  • Japan
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT03589326 on ClinicalTrials.gov