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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)

  • Clinicaltrials.gov identifier

    NCT03930953

  • Recruitment Status

    Recruiting

  • First Posted

    April 29, 2019

  • Last update posted

    February 8, 2022

Study Description

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:Lymphoma, Non-Hodgkin
  • Intervention/Treatment: Drug: CC-99282
    Drug: Rituximab
    Drug: Obinutuzumab
    Drug: Tafasitamab
    Drug: Tazemetostat
  • Phase: 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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 210 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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)
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: May 2024

Arms and interventions

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

Outcome Measures

  • 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 ]

Eligibility Criteria

  • 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

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, California
University of California, Irvine
Orange

United States, Florida
H Lee Moffitt Cancer Center
Tampa

United States, Missouri
Washington University
Saint Louis

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, Texas
MD Anderson Cancer Center
Houston

Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg

Austria
Universitätsklinikum St. Pölten
Sankt Pölten

Austria
Medical University Vienna
Vienna

Belgium
UZ Antwerpen
Edegem

Belgium
UZ Leuven
Leuven

Canada, Alberta
Cross Cancer Institute University of Alberta
Edmonton

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

Canada
McGill University Health Centre MUHC
Montreal

Denmark
Aarhus University Hospital
Aarhus C

Denmark
Rigshospitalet University Hospital
Copenhagen

Denmark
Vejle Hospital
Vejle

France
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux

France
Hopital Henri Mondor
Creteil

France
CHRU de Lille - Hopital Claude Huriez
Lillie Cedex

France
Centre Hospitalier Lyon-Sud
Pierre-Benite CEDEX

France
Centre Henri Becquerel
Rouen

France
Institut Claudius Regaud, IUCT-Oncopole
Toulouse

France
Gustave Roussy
Villejuif CEDEX

Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo

Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milano

Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"
Napoli

Spain
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona)

Spain
Vall d´Hebron University Hospital
Barcelona

Spain
Fundacion Jimenez Daaz
Madrid

Spain
Hospital La Paz
Madrid

Spain
Hospital Universitario Virgen De La Victoria
Malaga

Spain
Hospital Universitario de Salamanca
Salamanca

United Kingdom
Western General Hospital
Edinburgh Scotland

United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London

United Kingdom
Southampton General Hospital
Southhampton

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03930953 History of Changes
  • Other Study ID Numbers: CC-99282-NHL-001, U1111-1224-5399, 2018-003235-29
  • 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/
  • 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: Lymphoma
    Lymphoma, Non-Hodgkin
    Neoplasms by Histologic Type
    Neoplasms
    Lymphoproliferative Disorders
    Lymphatic Diseases
    Immunoproliferative Disorders
    Immune System Diseases