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RecruitingLast updated:29 July 2021

This trial is testing how safe and effective a new oral targeted therapy (Ponatinib) is when combined with chemotherapy in the treatment of children, adolescents and young adults diagnosed with Acute Lymphoblastic LeukemiaA Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation

Clinical summary Eligibilty Participating hospital Support

Clinical summary

Summary

Eligible patients will asked to take ponatinib once daily. In phase 1 ponatinib will be administered in combination with chemotherapy to determine the recommended phase 2 dose (RP2D) of ponatinib. In both phase 1 and phase 2, treatment consists of two 35-day blocks of therapy (reinduction block and consolidation block). Each block will include 29 days of treatment of daily ponatinib and chemotherapy, followed by a rest period from chemotherapy for a minimum of 6 days, during which time patients will receive daily ponatinib only.

Age

People 1 - 21

Phase

I/II

More information

Trial Identifiers

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NCT04501614

Commercial Sponsor

Takeda

Scientific Title

A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation

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Eligibility

Inclusion

You have certain types of non-cancer medical conditions.
You have been diagnosed with a prior or secondary type of cancer.
You have had certain treatments, surgical procedures or drugs.
You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

You are able to swallow medication by mouth.
You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
You have had treatment, but your cancer has come back.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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