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

Primary Purpose

Leukemia, Myeloid

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-96191
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid focused on measuring Acute Myeloid Leukemia, CC-96191, Relapsed or refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or 1.

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

8. 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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Mayo Clinic - JacksonvilleRecruiting
  • Winship Cancer Institute of Emory UniversityRecruiting
  • Mayo ClinicRecruiting
  • Hackensack University Medical CenterRecruiting
  • Mt. Sinai Medical Center Division of Hematology/OncologyRecruiting
  • The University of Texas - MD Anderson Cancer CenterRecruiting
  • Swedish Cancer InstituteRecruiting
  • Local Institution - 202Recruiting
  • Local Institution - 201Recruiting
  • Institut Paoli Calmette HematologieRecruiting
  • Hopital Saint LouisRecruiting
  • Hopital Haut LevequeRecruiting
  • Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CC-96191

Arm Description

CC-96191 will be administered intravenously on a 28-day Cycle

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLTs)
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)
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)
Type, frequency, seriousness, severity and relationship of AEs to CC-96191

Secondary Outcome Measures

Complete remission rate (CRR)
As defined by the European Leukemia Net (ELN) AML response criteria.
Objective response rate (ORR)
As defined by the European Leukemia Net (ELN) AML response criteria.
Progression-free survival (PFS)
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)
Is measured as the time from the first dose of CC-96191 to death due to any cause.
Duration of remission
For subjects with best response of complete remission (CR) of any type, morphologic leukemia free state (MLFS) or partial remission (PR), duration of response (DOR) is measured from the time when criteria for CR/MLFS/PR are first met (whichever is first recorded) until the first date at which relapse, or progressive disease is objectively documented
Time to remission
Time from the date of first dose to the earliest date of any response (CR of any type, MLFS or PR)
Pharmacokinetics - Cmax
Maximum serum concentration of drug
Pharmacokinetics - AUC
Area under the serum concentration time-curve
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration
Pharmacokinetics - t1/2
Terminal half-life
Pharmacokinetics - CL
Total body clearance of the drug from the serum
Pharmacokinetics - Vss
Volume of distribution at steady-state
Presence of anti-drug antibodies (ADA)
Detection of anti-drug antibodies in participants
Frequency of anti-drug antibodies (ADA)
Frequency of anti-drug antibodies in participants

Full Information

First Posted
February 26, 2021
Last Updated
September 27, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT04789655
Brief Title
Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Official Title
A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid
Keywords
Acute Myeloid Leukemia, CC-96191, Relapsed or refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CC-96191
Arm Type
Experimental
Arm Description
CC-96191 will be administered intravenously on a 28-day Cycle
Intervention Type
Drug
Intervention Name(s)
CC-96191
Intervention Description
CC-96191
Primary Outcome Measure Information:
Title
Dose limiting toxicities (DLTs)
Description
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.
Time Frame
Up to 42 days after the first dose
Title
Maximum tolerated dose (MTD)
Description
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.
Time Frame
Up to 35 days after the last dose
Title
Adverse Events (AEs)
Description
Type, frequency, seriousness, severity and relationship of AEs to CC-96191
Time Frame
Up to 35 days after the last dose
Secondary Outcome Measure Information:
Title
Complete remission rate (CRR)
Description
As defined by the European Leukemia Net (ELN) AML response criteria.
Time Frame
Up to approximately 2 years
Title
Objective response rate (ORR)
Description
As defined by the European Leukemia Net (ELN) AML response criteria.
Time Frame
Up to approximately 2 years
Title
Progression-free survival (PFS)
Description
Is defined as the time from the first dose of CC-96191 to the first occurrence of disease progression or death from any cause.
Time Frame
Up to approximately 2 years
Title
Overall survival (OS)
Description
Is measured as the time from the first dose of CC-96191 to death due to any cause.
Time Frame
Up to approximately 2 years
Title
Duration of remission
Description
For subjects with best response of complete remission (CR) of any type, morphologic leukemia free state (MLFS) or partial remission (PR), duration of response (DOR) is measured from the time when criteria for CR/MLFS/PR are first met (whichever is first recorded) until the first date at which relapse, or progressive disease is objectively documented
Time Frame
Up to approximately 2 years
Title
Time to remission
Description
Time from the date of first dose to the earliest date of any response (CR of any type, MLFS or PR)
Time Frame
Up to approximately 2 years
Title
Pharmacokinetics - Cmax
Description
Maximum serum concentration of drug
Time Frame
Up to 35 days after last dose
Title
Pharmacokinetics - AUC
Description
Area under the serum concentration time-curve
Time Frame
Up to 35 days after last dose
Title
Pharmacokinetics - tmax
Description
Time to peak (maximum) serum concentration
Time Frame
Up to 35 days after last dose
Title
Pharmacokinetics - t1/2
Description
Terminal half-life
Time Frame
Up to 35 days after last dose
Title
Pharmacokinetics - CL
Description
Total body clearance of the drug from the serum
Time Frame
Up to 35 days after last dose
Title
Pharmacokinetics - Vss
Description
Volume of distribution at steady-state
Time Frame
Up to 35 days after last dose
Title
Presence of anti-drug antibodies (ADA)
Description
Detection of anti-drug antibodies in participants
Time Frame
Up to 35 days after last dose
Title
Frequency of anti-drug antibodies (ADA)
Description
Frequency of anti-drug antibodies in participants
Time Frame
Up to 35 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 or 1. 7. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion without conditioning. 8. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center http://www.bmsstudyconnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pankit Vachhani, Site 109
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Foran, Site 105
Phone
205-934-2248
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Blum, Site 108
Phone
614-406-4123
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mithun Shah, Site 110
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Koprivnikar, Site 101
Facility Name
Mt. Sinai Medical Center Division of Hematology/Oncology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Mascarenhas, Site 102
Phone
212-241-4106
Facility Name
The University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tapan Kadia, Site 107
Phone
713-563-3534
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Egan, Site 111
Phone
617-699-2437
Facility Name
Local Institution - 202
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 202
Facility Name
Local Institution - 201
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 201
Facility Name
Institut Paoli Calmette Hematologie
City
Marseille cedex
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Garciaz, Site 303
Phone
0491223333
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Raffoux, Site 304
Phone
33142499649
Facility Name
Hopital Haut Leveque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Yves Dumas, Site 301
Facility Name
Gustave Roussy
City
Villejuif CEDEX
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane De Botton, Site 302
Phone
+33 1 42 11 40 79

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

Learn more about this trial

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

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