M14-387 : A Phase 1/2 Study of ABT-199 in Combination With Low-Dose Cytarabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are at Least 65 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

65+Age Over 65

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

This phase I/II trial is combining two chemotherapy drugs (venetoclax and cytarabine) in people who haven't received treatment for Acute Myelogenous Leukemia (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 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 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.

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 1/2 Study of ABT-199 in Combination With Low-Dose Cytarabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are at Least 65 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

Commercial Sponsor

AbbVie

Summary

This study consists of two phases: a Phase 1, or dose-escalation portion, that will evaluate the safety and pharmacokinetic profile of ABT-199 in combination with low-dose cytarabine (LDC), define the maximum tolerated dose (MTD), and generate data to support a recommended Phase 2 dose (RPTD) in treatment-naïve subjects with Acute Myelogenous Leukemia (AML); and a subsequent Phase 2 that will evaluate if the RPTD has sufficient efficacy and acceptable toxicity to warrant further development of the combination therapy.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Kate Reed
k.reed@alfred.org.au
03 9076 3571

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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