Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

 Acute myeloid leukaemia / Posted 3 months ago

To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine in AML and high risk MDS patients, and to identify recommended doses for future studies.

  • Inclusion Criteria :
    • 1. Written informed consent must be obtained prior to any screening procedures
    • 2. Male or female patients ≥ 18 years of age who present with one of the following: Arms 1-3:
    • Refractory/relapsed AML following ≥1 prior therapies and are deemed by the investigator not to be candidates for standard therapy, including re-induction with cytarabine or other established chemotherapy regimens for patients with AML (patients who are suitable for standard re-induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded)
    • De novo AML patients who are suitable for treatment with decitabine (patients who are suitable for standard induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded)
    • High risk MDS (patients who are suitable for standard re-induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded) Arms 4-5:
    • Refractory / relapsed AML following ≥1 prior therapies (Arms 4a & 5a)
    • High risk MDS who have failed hypomethylating agent therapy (Arms 4b & 5b) (Note: hypomethylating agent failure is defined as progressive disease on hypomethylating agent therapy or lack of clinically meaningful response as deemed by investigator after at least 4 cycles of hypomethylating agent therapy.)
    • 3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    • 4. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and be willing to undergo a bone marrow aspirate and/biopsy at screening, during and at the end of therapy on this study. Exceptions may be considered after documented discussion with Novartis.
    • 5. Arms 1-3: Patients must be fit for standard treatment with decitabine as determined by the investigator and as per local decitabine package insert.
  • Study end date : 01/11/2021
  • Wales-Based Study Contact : Please speak to your clinician
Contact details

Novartis Investigative Site Cardiff, United Kingdom, CF4 4XNCardiff Novartis.email@novartis.com

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