PonAZA : A phase Ib/II clinical evaluation of Ponatinib in combination with 5-azacytidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AML M21)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

This phase I/II trial is combining an oral drug (ponatinib) with 5- azacitidine for the treatment of Acute Myeloid Leukaemia (AML).
 

This trial is treating patients with Acute Myeloid Leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

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

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A phase Ib/II clinical evaluation of Ponatinib in combination with 5-azacytidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AML M21)

Cooperative Group

Australasian Leukaemia and Lymphoma Group (ALLG)

Summary

The study is evaluating Ponatinib in combination with 5-azacytidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AML M21). Who is it for? You may be eligible to join this study if you are aged over 18 years, have enrolled in the Australasian Leukaemia and Lymphoma Acute Myeloid Leukaemia ( ALLG AML) registry, have FLT3-ITD AML (except Acute Promyelocytic Leukaemia) failing prior chemotherapy (excluding hydroxyurea and thioguanine). This study has two parts: Phase Ib which involves finding the best dose of Azacytidine to combine with Ponatinib in terms of patient tolerability and safety. In Phase II of the study, patients will be randomly (by chance) assigned to 3 groups; one group will receive Ponatinib alone, the other will receive Azacytidine alone and the last group will receive both drugs.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Mary Lane
m.lane@alfred.org.au
03 9076 5281

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

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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