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RecruitingLast updated:15 August 2023

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 syndromeA 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)

Clinical summary

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.

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People18+

Phase

I

More information

Trial Identifiers

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Commercial Sponsor

Novartis Pharmaceuticals

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)

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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