NCT03930953Active, not recruitingPhase 1/2
An early study to investigate a new medicine for Subjects with Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
A PHASE I/II, 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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Jul 2026
Brief summary (registry, in English)
1. To determine the safety and tolerability of CC-99282 alone and in combination with rituximab, obinutuzumab, tafasitamab, or valemetostat ± rituximab in subjects with R/R NHL 2. To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 doses (RP2D) of CC-99282 as monotherapy or in combination with anti-lymphoma agents in subjects with R/R NHL
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- 10 May 2019
- Lead sponsor
- Celgene Corp.
- NCT number
- NCT03930953
- EU CT number
- 2024-515690-10-00
- EudraCT number
- 2018-003235-29
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 204
- 21 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location).
- Subject has received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting investigational product(s), whichever is shorter.
- Subject had prior autologous SCT ≤ 3 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1).
- Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1).
Other illness
- Subject has symptomatic CNS involvement of disease (does not apply to PCNSL subjects in Part B).
- Subject is on chronic systemic immunosuppressive therapy or corticosteroids (eg, prednisone or equivalent not to exceed 10 mg per day within the last 14 days) or subjects with clinically significant graft versus- host disease (GVHD).
Other
- Subject has life expectancy ≤ 2 months.
Who the study is looking for
- Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
- Subject has a history of NHL (including DLBCL, FL, MZL, MCL and PCNSL) with relapsed or refractory disease
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Subjects must have the following laboratory values: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L or ≥ 1 x 10^9/L in case of documented bone marrow involvement, without growth factor support for 7 days (14 days if pegfilgastrim) b. Hemoglobin (Hgb) ≥ 8 g/dL c. Platelets (plt) ≥ 75 x 10^9/L or ≥ 50 x 10^9/L in case of documented bone marrow involvement, without transfusion for 7 days d. Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). e. AST/SGOT and ALT/SGPT ≤ 2.5X ULN f. Estimated serum creatinine clearance of > 30 mL/min using the Cockcroft-Gault equation or directly determined from the 24-hour urine collection method or using the modification of diet in renal disease (MDRD) formula. For Cohort G and H, estimated serum creatinine clearance of ≥ 45 mL/min using the Cockcroft-Gault equation or directly determined from the 24-hour urine collection method or using the modification of diet in renal disease (MDRD) formula.
- Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Sygehus Lillebaelt - Vejle Sygehus Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.