Evaluating CC-99282 for relapsed or refractory non-Hodgkin lymphomas
A Phase 1/2, 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).
This study is testing a new treatment called CC-99282 for people with non-Hodgkin lymphomas that haven't responded to previous therapies to see how safe and effective it is.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 438 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celgene Industry-sponsored |
| Locations | 92 sites (Scottsdale, Arizona and 91 other locations) |
| Trial ID | NCT03930953 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and preliminary efficacy of CC-99282, both as a standalone treatment and in combination with other anti-lymphoma agents, for patients with relapsed or refractory non-Hodgkin's lymphomas. Participants must have previously failed at least two lines of therapy or be ineligible for further standard treatments. The study includes a dose escalation phase to determine the maximum tolerated dose of CC-99282 and a dose expansion phase to further evaluate its efficacy. Additionally, the study will investigate the effects of food on the pharmacokinetics and safety of CC-99282.
Who should consider this trial
Good fit: Ideal candidates are individuals with relapsed or refractory non-Hodgkin's lymphoma who have failed multiple prior therapies.
Not a fit: Patients with a life expectancy of two months or less or those with significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat non-Hodgkin lymphomas.
How similar studies have performed: Other studies have shown promise with similar approaches in treating non-Hodgkin lymphomas, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scottsdale, Arizona and 91 other locations
- Mayo Clinic Arizona - Scottsdale — Scottsdale, Arizona, United States (Recruiting)
- UCSD Moores Cancer Center — La Jolla, California, United States (Withdrawn)
- Local Institution - 114 — Los Angeles, California, United States (Withdrawn)
- University of California, Irvine — Orange, California, United States (Withdrawn)
- Oncology Institute of Hope and Innovation — Whittier, California, United States (Withdrawn)
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States (Recruiting)
- H Lee Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- The University of Kansas - Clinical Research Center — Overland Park, Kansas, United States (Withdrawn)
- The University of Kansas - Clinical Research Center — Overland Park, Kansas, United States (Recruiting)
- University Of Maryland At Baltimore — Baltimore, Maryland, United States (Withdrawn)
- Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (Withdrawn)
- Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (Recruiting)
- Local Institution - 104 — Saint Louis, Missouri, United States (Completed)
- Local Institution - 103 — Hackensack, New Jersey, United States (Completed)
- Local Institution - 106 — Mineola, New York, United States (Withdrawn)
- Perlmutter Cancer Center at NYU Langone Hospital-Long Island — Mineola, New York, United States (Withdrawn)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Hospital Aleman — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (Recruiting)
- Local Institution - 251 — Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina (Withdrawn)
- Local Institution - 254 — Pilar, Buenos Aires, Argentina (Not_yet_recruiting)
- Local Institution - 250 — Buenos Aires, Argentina (Withdrawn)
- Local Institution - 253 — Buenos Aires, Argentina (Completed)
- Local Institution - 252 — Cordoba, Argentina (Withdrawn)
- Local Institution - 701 — Salzburg, Austria (Completed)
- Local Institution - 704 — St. Polten, Austria (Completed)
- Local Institution - 703 — Vienna, Austria (Completed)
- Local Institution - 903 — Edegem, Belgium (Withdrawn)
- Local Institution - 901 — Leuven, Belgium (Withdrawn)
- Local Institution - 902 — Leuven, Belgium (Completed)
- Hospital São Lucas da PUCRS — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital israelita Albert Einstein — Sao Paulo, Sp, Brazil (Recruiting)
- Instituto D'Or de Pesquisa e Ensino (IDOR) — São Paulo, Brazil (Recruiting)
- Local Institution - 452 — São Paulo, Brazil (Completed)
- Local Institution - 203 — Edmonton, Alberta, Canada (Withdrawn)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- Clínica Inmunocel — Santiago, Metropolitana DE Santiago, Chile (Recruiting)
- Bradford Hill — Recoleta, Metropolitana, Chile (Recruiting)
- Fundacion Oncologia Arturo Lopez Perez — Santiago, Metropolitana, Chile (Recruiting)
- Pontificia Universidad Catolica de Chile-Hemato-Oncology — Santiago, Metropolitana, Chile (Recruiting)
- Local Institution - 350 — Santiago, Rm, Chile (Completed)
- Local Institution - 0909 — Santiago, Chile (Withdrawn)
- Local Institution - 351 — Santiago, Chile (Withdrawn)
- Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
- Local Institution - 656 — Xiamen, Fujian, China (Withdrawn)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Local Institution - 652 — Haerbin, Heilongjiang, China (Withdrawn)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- Hubei Cancer Hospital — Wuhan Shi, Hubei, China (Recruiting)
- The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
+42 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.