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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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus Universitetshospital
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Aarhus NDenmarkRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Sygehus Lillebaelt - Vejle Sygehus
Coordinator of this site? Confirm its status
VejleDenmarkRecruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Institut Bergonie
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BordeauxFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Henri Becquerel
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Rouen CedexFranceActive, not recruiting
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.