NCT04501614 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

One/TwoPhase One/Two

1-21Age 1-21

Blood<br/>CancersCancer LocationBlood
Cancers

Treatment | Blood / Myeloma / LymphomaChronic Lymphocytic Leukaemia,Leukaemia

Trial Overview Read MoreRead more

This trial aims to determine the effectiveness of an anticancer drug when combined with chemotherapy in paediatric patients with Acute Lymphoblastic Leukemia .
 

This trial is treating patients with Children and adolescences with Acute Lymphoblastic Leukemia (ALL) or Have the T315I Mutation.

This is a Systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You are currently receiving treatment for your cancer.
  • You have had a certain type of treatment or surgical procedure.
  • 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.
  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

Takeda

Summary

Eligible patients will asked to take ponatinib once daily. In phase 1 ponatinib will be administered in combination with a chemotherapy backbone to determine the recommended phase 2 dose (RP2D) of ponatinib. n 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 a chemotherapy backbone regimen followed by a rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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