Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

STIMULUS-MDS2 : A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaChronic Myelogenous Leukaemia,Myelodysplasia

Trial Overview Read MoreRead more

This Phase III trial is trying to understand the effect of a new immunotherapy (MBG453) in combination with chemotherapy (azacitidine) compared with azacitidine and a placebo in people with intermediate, high or very high risk myelodysplastic syndrome or chronic myelomonocytic leukaemia-2.
 

This trial is treating patients with myelodysplastic syndromes and chronic myelomonocytic leukaemia.

This is a systemic therapy trial.

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.

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 Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

Commercial Sponsor

Novartis Pharmaceuticals

Summary

This is a randomised trial with experimental and placebo comparator arms. Participants in the Experimental Arm will receive MBG453 plus Azacitidine. A dose of MBG453 800 mg will be administered intravenously (IV) every 4 weeks (Q4W).A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9. Participants in the Placebo Comparator Arm will receive a placebo plus Azacitidine. A dose of Placebo 800 mg will be administered intravenously every 4 weeks (Q4W). A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9.

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@monashhealth.org
03 9594 4044

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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