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A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

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: NCT03930953
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: CC-99282 Drug: Rituximab Drug: Obinutuzumab Drug: Tafasitamab Drug: Tazemetostat Phase 1

Detailed Description:

Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy).

The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy.

The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 administered at or below MTD in subjects with R/R DLBCL and NHL. Part B will also evaluate the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and R/R FL.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed OR Refractory Non-Hodgkin Lymphomas (R/R NHL).
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : June 11, 2023
Estimated Study Completion Date : May 13, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Part A: Dose Escalation Drug: CC-99282
Specified dose on specified days

Experimental: Part B: Dose Expansion Drug: CC-99282
Specified dose on specified days

Drug: Rituximab
Specified dose on specified days

Drug: Obinutuzumab
Specified dose on specified days

Drug: Tafasitamab
Specified dose on specified days

Drug: Tazemetostat
Specified dose on specified days




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days in Cycle 1 ]
  2. Maximum tolerated dose (MTD) [ Time Frame: Up to 28 days in cycle 1 ]
  3. Incidence of Adverse Events (AEs) [ Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 2 years) ]

Secondary Outcome Measures :
  1. Pharmacokinetics - Maximum observed plasma concentration (Cmax) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  2. Pharmacokinetics - Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  3. Pharmacokinetics - Time to Cmax (Tmax) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  4. Pharmacokinetics - Terminal-phase elimination half-life (t1/2) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  5. Pharmacokinetics - Apparent total clearance of the drug from plasma after oral administration (CL/F) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  6. Pharmacokinetics: Apparent volume of distribution during terminal phase after non-intravenous administration (V/F) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  7. Objective response rate (ORR) [ Time Frame: Up to approximately 3 years ]
  8. Time to response (TTR) [ Time Frame: Up to approximately 3 years ]
  9. Duration of response (DoR) [ Time Frame: Up to approximately 3 years ]
  10. Progression free survival: Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause [ Time Frame: Up to approximately 3 years ]
  11. Overall survival: Time from first dose of CC-99282 to death from any cause [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

  • History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

  • Life expectancy ≤ 2 months
  • Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter
  • Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
  • Impaired cardiac function or clinically significant cardiac disease

Other protocol-defined inclusion/exclusion criteria apply


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): NCT03930953


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
Show Show 35 study locations
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: NCT03930953    
Other Study ID Numbers: CC-99282-NHL-001
U1111-1224-5399 ( Registry Identifier: WHO )
2018-003235-29 ( EudraCT Number )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 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:
Non-Hodgkin Lymphomas (NHL)
Safety
Efficacy
CC-99282
Rituximab
Relapsed
Refractory
Pharmacokinetics
Obinutuzumab
Tafasitamab
Tazemetostat
Anti-lymphoma agents
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents