This website is intended for healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • Clinicaltrials.gov identifier

    NCT04789655

  • Recruitment Status

    Recruiting

  • First Posted

    March 9, 2021

  • Last update posted

    November 10, 2021

Study Description

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:Leukemia, Myeloid
  • Intervention/Treatment: Drug: CC-96191
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 70 participants
  • 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 2021
  • Estimated Primary Completion Date: February 2025
  • Estimated Study Completion Date: February 2025

Arms and interventions

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

Outcome Measures

  • 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

Eligibility Criteria

  • 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: Participant is suspected or proven to have acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype. 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. 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). Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing. 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. Participant has persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2. 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. History of concurrent second cancers requiring active, ongoing systemic treatment. Participant is known seropositive or active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus or hepatitis C virus. Impaired cardiac function or clinically significant cardiac diseases, as defined in the protocol . Participant is a pregnant or lactating female.

Contacts and Locations

Contacts

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

United States, Alabama
University of Alabama at Birmingham
Birmingham

United States, Florida
Mayo Clinic - Jacksonville
Jacksonville

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, New York
Mt. Sinai Medical Center Division of Hematology/Oncology
New York

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

Canada, Ontario
Princess Margaret Hospital University Health Network
Toronto

France
Institut Paoli Calmette Hematologie
Marseille cedex

France
Hopital Saint Louis
Paris

France
Hopital Haut Leveque
Pessac Cedex

France
Gustave Roussy
Villejuif CEDEX

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04789655 History of Changes
  • Other Study ID Numbers: CC-96191-AML-001, U1111-1264-5412
  • First Posted: March 9, 2021 Key Record Dates
  • Last Update Posted: November 10, 2021
  • Last Verified: November 2021
  • 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/
  • 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: Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Neoplasms by Histologic Type
    Neoplasms