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Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04789655
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: CC-96191
CC-96191 will be administered intravenously on a 28-day Cycle
Drug: CC-96191
CC-96191




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse Events (AEs) [ Time Frame: Up to 35 days after the last dose ]
    Type, frequency, seriousness, severity and relationship of AEs to CC-96191


Secondary Outcome Measures :
  1. Complete remission rate (CRR) [ Time Frame: Up to approximately 2 years ]
    As defined by the European Leukemia Net (ELN) AML response criteria.

  2. Objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]
    As defined by the European Leukemia Net (ELN) AML response criteria.

  3. 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.

  4. 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.

  5. Pharmacokinetics - Cmax [ Time Frame: Up to 35 days after last dose ]
    Maximum serum concentration of drug

  6. Pharmacokinetics - AUC [ Time Frame: Up to 35 days after last dose ]
    Area under the serum concentration time-curve

  7. Pharmacokinetics - tmax [ Time Frame: Up to 35 days after last dose ]
    Time to peak (maximum) serum concentration

  8. Pharmacokinetics - t1/2 [ Time Frame: Up to 35 days after last dose ]
    Terminal half-life

  9. Pharmacokinetics - CL [ Time Frame: Up to 35 days after last dose ]
    Total body clearance of the drug from the serum

  10. Pharmacokinetics - Vss [ Time Frame: Up to 35 days after last dose ]
    Volume of distribution at steady-state

  11. Presence of anti-drug antibodies (ADA) [ Time Frame: Up to 35 days after last dose ]
    Detection of anti-drug antibodies in participants

  12. Frequency of anti-drug antibodies (ADA) [ Time Frame: Up to 35 days after last dose ]
    Frequency of anti-drug antibodies in participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

1. Participant must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.

3. Participant is ≥ 18 years of age at the time of signing the ICF. 4. Relapsed or refractory CD33 positive AML at last visit as defined by the World Health Organization (WHO) Classification who have failed or who are ineligible for or have refused all available therapies for AML which may provide clinical benefit.

6. Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.

7. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion without conditioning.

8. Participants must have adequate hematologic, liver, renal, and coagulation function as assessed by laboratory tests 9. Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and during the safety follow-up period.

Exclusion Criteria:

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

  1. Participant is suspected or proven to have acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype.
  2. Participant has received systemic anticancer therapy (including investigational therapy) or radiotherapy < 28 days or 5 half-lives, whichever is shorter, prior to the start of study treatment. Hydroxyurea is allowed to control peripheral leukemia blasts.
  3. Participants with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (eg, transplant-related side effects).
  4. Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing.
  5. Participants on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted.
  6. Participant has persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2.
  7. Participant has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.
  8. History of concurrent second cancers requiring active, ongoing systemic treatment.
  9. Participant is known seropositive or active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus or hepatitis C virus.
  10. Impaired cardiac function or clinically significant cardiac diseases, as defined in the protocol .
  11. Participant is a pregnant or lactating female.

Information from the National Library of Medicine

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


Contacts
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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 #

Locations
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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
Canada, Alberta
Tom Baker Cancer Center Not yet recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Princess Margaret Hospital University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
France
Institut Paoli Calmette Hematologie Recruiting
Marseille cedex, France, 13273
Hopital Saint Louis Recruiting
Paris, France, 75010
Hopital Haut Leveque Recruiting
Pessac Cedex, France, 33604
Gustave Roussy Recruiting
Villejuif CEDEX, France, 94805
Local Institution - 302 Recruiting
Villejuif CEDEX, France, 94805
Contact: Site 302         
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04789655    
Other Study ID Numbers: CC-96191-AML-001
U1111-1264-5412 ( Registry Identifier: WHO )
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Acute Myeloid Leukemia
CC-96191
Relapsed or refractory
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms