Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04789655|
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : April 25, 2022
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML).
The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy.
The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid||Drug: CC-96191||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||June 16, 2021|
|Estimated Primary Completion Date :||February 1, 2025|
|Estimated Study Completion Date :||February 1, 2025|
CC-96191 will be administered intravenously on a 28-day Cycle
- Dose limiting toxicities (DLTs) [ Time Frame: Up to 42 days after the first dose ]Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to at least 28 and up to 42 days) that cannot be attributed to a clearly identifiable cause such as underlying illness, disease progression, other concurrent illness, or concomitant medication.
- Maximum tolerated dose (MTD) [ Time Frame: Up to 35 days after the last dose ]Is defined as the highest dose at which less than 33% of the population treated with CC-96191 experience a dose limiting toxicity (DLT) in the first cycle.
- Adverse Events (AEs) [ Time Frame: Up to 35 days after the last dose ]Type, frequency, seriousness, severity and relationship of AEs to CC-96191
- Complete remission rate (CRR) [ Time Frame: Up to approximately 2 years ]As defined by the European Leukemia Net (ELN) AML response criteria.
- Objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]As defined by the European Leukemia Net (ELN) AML response criteria.
- Progression-free survival (PFS) [ Time Frame: Up to approximately 2 years ]Is defined as the time from the first dose of CC-96191 to the first occurrence of disease progression or death from any cause.
- Overall survival (OS) [ Time Frame: Up to approximately 2 years ]Is measured as the time from the first dose of CC-96191 to death due to any cause.
- Pharmacokinetics - Cmax [ Time Frame: Up to 35 days after last dose ]Maximum serum concentration of drug
- Pharmacokinetics - AUC [ Time Frame: Up to 35 days after last dose ]Area under the serum concentration time-curve
- Pharmacokinetics - tmax [ Time Frame: Up to 35 days after last dose ]Time to peak (maximum) serum concentration
- Pharmacokinetics - t1/2 [ Time Frame: Up to 35 days after last dose ]Terminal half-life
- Pharmacokinetics - CL [ Time Frame: Up to 35 days after last dose ]Total body clearance of the drug from the serum
- Pharmacokinetics - Vss [ Time Frame: Up to 35 days after last dose ]Volume of distribution at steady-state
- Presence of anti-drug antibodies (ADA) [ Time Frame: Up to 35 days after last dose ]Detection of anti-drug antibodies in participants
- Frequency of anti-drug antibodies (ADA) [ Time Frame: Up to 35 days after last dose ]Frequency of anti-drug antibodies in participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789655
|Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,||please email:||Clinical.Trials@bms.com|
|Contact: First line of the email MUST contain the NCT# and Site #|
|United States, Alabama|
|University of Alabama at Birmingham||Not yet recruiting|
|Birmingham, Alabama, United States, 35233|
|United States, Florida|
|Mayo Clinic - Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32224|
|United States, Georgia|
|Winship Cancer Institute of Emory University||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|United States, Minnesota|
|Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Hackensack University Medical Center||Not yet recruiting|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Mt. Sinai Medical Center Division of Hematology/Oncology||Recruiting|
|New York, New York, United States, 10029|
|United States, Texas|
|The University of Texas - MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Swedish Cancer Institute||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Tom Baker Cancer Center||Not yet recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Princess Margaret Hospital University Health Network||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Institut Paoli Calmette Hematologie||Recruiting|
|Marseille cedex, France, 13273|
|Hopital Saint Louis||Recruiting|
|Paris, France, 75010|
|Hopital Haut Leveque||Recruiting|
|Pessac Cedex, France, 33604|
|Villejuif CEDEX, France, 94805|
|Local Institution - 302||Recruiting|
|Villejuif CEDEX, France, 94805|
|Contact: Site 302|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|