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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Non-Hodgkin | Drug: CC-99282 Drug: Rituximab Drug: Obinutuzumab Drug: Tafasitamab Drug: Tazemetostat | Phase 1 |
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 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 |
| 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 |
- Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days in Cycle 1 ]
- Maximum tolerated dose (MTD) [ Time Frame: Up to 28 days in cycle 1 ]
- 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) ]
- Pharmacokinetics - Maximum observed plasma concentration (Cmax) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
- Pharmacokinetics - Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
- Pharmacokinetics - Time to Cmax (Tmax) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
- Pharmacokinetics - Terminal-phase elimination half-life (t1/2) [ Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) ]
- 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) ]
- 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) ]
- Objective response rate (ORR) [ Time Frame: Up to approximately 3 years ]
- Time to response (TTR) [ Time Frame: Up to approximately 3 years ]
- Duration of response (DoR) [ Time Frame: Up to approximately 3 years ]
- 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 ]
- Overall survival: Time from first dose of CC-99282 to death from any cause [ Time Frame: Up to approximately 3 years ]
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 #. |
Show 35 study locations
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
| 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/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Non-Hodgkin Lymphomas (NHL) Safety Efficacy CC-99282 Rituximab Relapsed |
Refractory Pharmacokinetics Obinutuzumab Tafasitamab Tazemetostat Anti-lymphoma agents |
|
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 |