CULMINATE : A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy,Treatment | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia,Leukaemia,Myelodysplasia

Trial Overview Read MoreRead more

This phase II trial will evaluate two different doses of a targeted therapy in combination with a standard dose of azacitidine in patients with acute myeloid leukaemia or high-risk myelodysplastic syndrome.
 

This trial is treating patients with acute myeloid leukaemia or high-risk myelodysplastic syndrome.

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 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Commercial Sponsor

Janssen Research & Development, LLC

Summary

Eligible patients will be randomised to receive 75mg per metre square (mg/m^2) of subcutaneous or intravenous azacitidine on Day 1 through Day 7 of each 28-day cycle and either 10mg/kg or 20mg/kg of intravenous cusatuzumab on Day 3 and Day 17 of each 28-day cycle.

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

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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