Acute Myeloid Leukemia Clinical Trial

Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

Summary

Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 dose (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 40 participants may be enrolled in Part A of the study.

The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Separate expansion cohorts for participants with R/R AML and R/R HR-MDS may enroll approximately 20 to 40 response evaluable participants per cohort.

Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must satisfy the criteria below to be enrolled in the Dose Escalation (Part A) or the Dose Expansion (Part B) of this study.

Participant is ≥ 18 years of age, at the time of signing the ICF.
Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
Relapsed or refractory acute myeloid leukemia (R/R AML) and relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS) as defined by the World Health Organization (WHO) criteria who have failed or are ineligible for all available therapies which may provide clinical benefit
Participant has Eastern Cooperative Oncology Group Performance Status of 0 to 2.

Participants must have the following screening laboratory values:

Total White Blood Cell count (WBC) < 25 x 109/L prior to first infusion.
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN), unless considered due to leukemic organ involvement, in which case AST and ALT can be ≤ 5.0 x ULN.
Uric acid ≤ 7.5 mg/dL (446 μmol/L).
Serum total bilirubin ≤ 1.5 x ULN, unless considered due to Gilbert's syndrome
Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated.
INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

Participant has any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant were to participate in the study.
Any other significant medical condition, laboratory abnormality, or psychiatric illness which places the participant at unacceptable risk if he/she were to participate in the study or that would prevent the participant from complying with the study.
Participant has any condition that confounds the ability to interpret data from the study.
Participants with acute promyelocytic leukemia.
Participants with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia.
Participants with immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation.
Participants with impaired cardiac function or clinically significant cardiac diseases,
Participants who have undergone major surgery ≤ 2 weeks prior to starting CC-91633. Participants must have recovered from any clinically significant effects of recent surgery.
Pregnant or nursing individuals.
Participants with known human immunodeficiency virus infection.
Participants with known chronic, active hepatitis B virus or hepatitis C virus C (HCV) infection.
Participants with ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors).
Participants with history of concurrent second cancers requiring active, ongoing systemic treatment
Participants with clinically significant diarrhea, vomiting or malabsorption felt to limit absorption of orally administered medications.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT04951778

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 27 Locations for this study

See Locations Near You

Local Institution - 111
Gilbert Arizona, 85234, United States More Info
Site 111
Contact
Local Institution - 103
La Jolla California, 92093, United States
Northwestern University School Of Medicine
Chicago Illinois, 60611, United States
Local Institution - 110
Chicago Illinois, 60637, United States More Info
Site 110
Contact
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Andrew Brunner, Site 107
Contact
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Daniel DeAngelo, Site 101
Contact
617-632-3712
Washington Univ School of Medicine Siteman Cancer Center
Saint Louis Missouri, 63110, United States More Info
Geoffrey Uy, Site 105
Contact
314-454-8304
Local Institution - 102
Columbus Ohio, 43210, United States
Local Institution - 108
Philadelphia Pennsylvania, 19104, United States More Info
Site 108
Contact
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Courtney DiNardo, Site 104
Contact
713-794-1141
Local Institution - 109
Seattle Washington, 98104, United States More Info
Site 109
Contact
Local Institution - 604
Adelaide South Australia, 5000, Australia More Info
Site 604
Contact
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Monash Health
Clayton Victoria, 3168, Australia More Info
Jake Shortt, Site 602
Contact
+61395944044
The Alfred Hospital
Melbourne Victoria, 3004, Australia More Info
Shaun Fleming, Site 601
Contact
Local Institution - 603
Melbourne Victoria, 3065, Australia More Info
Site 603
Contact
St Vincent's Hospital
Melbourne Victoria, 3065, Australia
Local Institution - 203
Vancouver British Columbia, V5Z 1, Canada More Info
Site 203
Contact
Local Institution - 201
Ottawa Ontario, K1H 8, Canada More Info
Site 201
Contact
Local Institution - 202
Toronto Ontario, M5G 2, Canada More Info
Site 202
Contact
Vall d Hebron University Hospital
Barcelona , 08035, Spain More Info
Olga Salamero, Site 302
Contact
+34932746000 00 00
Hospital Clinic de Barcelona
Barcelona , 08036, Spain More Info
Jordi Esteve, Site 301
Contact
Local Institution - 303
Madrid , 28041, Spain More Info
Site 303
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Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain More Info
Eduardo Rodriguez Arboli, Site 304
Contact
Local Institution - 504
Manchester Greater Manchester, M20 4, United Kingdom More Info
Site 504
Contact
Local Institution - 502
London London, City Of, SE5 9, United Kingdom More Info
Site 502
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Local Institution - 503
Leeds , LS9 7, United Kingdom More Info
Site 503
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Local Institution - 505
London , W1T 7, United Kingdom More Info
Site 505
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Local Institution - 501
Oxford , OX3 7, United Kingdom More Info
Site 501
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How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT04951778

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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