ALLG APML5 : A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Promyelocytic Leukaemia,Leukaemia

Trial Overview Read MoreRead more

This phase I trial is evaluating an oral anti-cancer drug (arsenic trioxide) as a consolidation therapy for acute promyelocytic leukaemia (APML).
 

This trial is treating patients with Acute Promyelocytic Leukaemia (APML).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

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 phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia

Cooperative Group

Australasian Leukaemia and Lymphoma Group (ALLG)

Summary

This trial has a randomised design, consisting of two parts. In part 1, patients will receive 7 cycles of All-Trans Retinoic Acid (ATRA, tretinoin) (45mg/m^2, in 2 divided doses) + 4 cycles of IV ATO (0.15mg/kg/day) with the exception of week one of ATO cycle #2, and week one of ATO cycle # 4, when oral tablet ATO (0.15mg/kg/day) will be used. In part 2 of the trial, patients will receive Patients will be given 7 cycles of ATRA (45mg/m^2, in 2 divided doses) + 4 cycles of IV ATO, with the exception of week one of either ATO cycle #1 or ATO cycle #2, and week one of either ATO cycle #3 or ATO cycle #4, when oral tablet ATO will be used (sequence will be determined by randomisation).

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Nola Kennedy
n.kennedy@alfred.org.au
03 9076 2217

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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