CC-90009 for Leukemia and Myelodysplastic Syndrome
Recruiting at40 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Celgene
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called CC-90009 in patients with certain blood cancers that have come back or didn't respond to treatment. The study aims to find the safest and most effective dose by adjusting the amount given to patients over time.
Research Team
BS
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
Adults with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS), who are not suitable for other therapies. Participants must have certain normal lab values, an ECOG Performance Status of 0-2, and cannot have had recent leukapheresis, CNS leukemia symptoms, significant graft-versus-host disease post-transplant, or recent cancer treatments.Inclusion Criteria
It has been over 4 weeks since my last donor lymphocyte infusion without any prior preparation.
Uric acid ≤ 7.5 mg/dL
Selected electrolytes within normal limits or correctable with supplements
See 11 more
Exclusion Criteria
I have been diagnosed with acute promyelocytic leukemia.
I had a stem cell transplant and haven't fully recovered yet.
I am on immune-suppressing drugs after a stem cell transplant or have significant graft-versus-host disease.
See 4 more
Treatment Details
Interventions
- CC-90009 (BCL-2 Inhibitor)
Trial OverviewThe study is testing different doses of a drug called CC-90009 to find the safest and most effective amount for treating AML and HR-MDS. It's an early-phase trial where all participants receive CC-90009; there's no comparison group receiving another treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: CC-90009 - Part B - AML and MDS patientsExperimental Treatment1 Intervention
Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A
Group II: CC-90009 - Part AExperimental Treatment1 Intervention
Will be administered intravenously per dosing schedule in a 28-day cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Trials
649
Recruited
130,000+
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Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania