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Closed (no longer recruiting)Last updated: 7 February 2024

OMNIVERSE: This phase I study is evaluating how safe, tolerable and effective an oral drug (CC-486) is in combination with targeted therapy (venetoclax) in people with relapsed, refractory or newly diagnosed acute myeloid leukaemiaA Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)

Clinical summary

Summary

All eligible participants will receive oral CC-486 in combination with venetoclax.

Conditions

This trial is treating patients with acute myeloid leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

OMNIVERSE

More information

Trial Identifiers

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Trial sponsor

Celgene Corporation

Scientific Title

A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)

Eligibility

Inclusion

  • Confirmation of the following for Acute Myeloid Leukemia (AML)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities
  • Agree to serial bone marrow aspirate/biopsies

Exclusion

  • Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
  • Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy
  • Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • You are able to swallow medication by mouth.
  • 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 have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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

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