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RecruitingLast updated: 30 January 2024

M16-183: This phase I trial is evaluating two drugs (one oral and one intravenous) in Acute Myeloid Leukaemia (AML) patients who have got worse or not responded to treatmentPhase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukaemia

Clinical summary

Summary

This trial has a single group assignment. Oral Venetoclax and intravenous Dinaciclib will be administered in combination, with different combinations of dose levels explored.

Conditions

This trial is treating patients with Acute Myeloid Leukaemia (AML)

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

M16-183

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukaemia

Eligibility

Inclusion

  • Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion

  • Known central nervous system leukemia
  • Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
  • History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
  • Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
  • History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
  • Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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