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

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days in Cycle 1 ]
  
• Primary Outcome Measures: 2. Maximum tolerated dose (MTD) [ Time Frame: Up to 28 days in cycle 1 ]
  
• Primary Outcome Measures: 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) ]
  
• Secondary Outcome Measures: 2. Pharmacokinetics - Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  
• Secondary Outcome Measures: 3. Pharmacokinetics - Time to Cmax (Tmax) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  
• Secondary Outcome Measures: 4. Pharmacokinetics - Terminal-phase elimination half-life (t1/2) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
  
• Secondary Outcome Measures: 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) ]
  
• Secondary Outcome Measures: 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) ]
  
• Secondary Outcome Measures: 7. Objective response rate (ORR) [ Time Frame: Up to approximately 3 years ]
  
• Secondary Outcome Measures: 8. Time to response (TTR) [ Time Frame: Up to approximately 3 years ]
  
• Secondary Outcome Measures: 9. Duration of response (DoR) [ Time Frame: Up to approximately 3 years ]
  
• Secondary Outcome Measures: 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 ]
  
• Secondary Outcome Measures: 11. Overall survival: Time from first dose of CC-99282 to death from any cause [ Time Frame: Up to approximately 3 years ]
  

Eligibility Criteria

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

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