NCT03940352 : A Phase Ib, Multi-arm, Open-label, Study of HDM201 in Combination With MBG453 or Venetoclax in Adult Subjects With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

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,Treatment | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia,Essential Thrombocytosis,Leukaemia,Myelodysplasia,Polycythaemia vera

Trial Overview Read MoreRead more

This phase I trial is studying a new oral cancer drug in combination with immunotherapy or chemotherapy for the treatment of acute myeloid leukaemia or high-risk myelodysplastic syndrome.
 

This trial is treating patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS).

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 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 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

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase Ib, Multi-arm, Open-label, Study of HDM201 in Combination With MBG453 or Venetoclax in Adult Subjects With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

Commercial Sponsor

Novartis Pharmaceuticals

Summary

This trial will run across two treatment arms. In Treatment Arm 1, eligible patients will receive HDM201 in combination with MBG453. In Treatment Arm 2, patients will receive HDM201 in combination with venetoclax, which will be gradually increased (ramp-up) over a period of 4 to 5 days to achieve the daily target dose tested that will be subsequently continued.

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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