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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)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515690-10-00
Acronym
CC-99282-NHL-001
Enrollment
204
Registered
2024-09-23
Start date
2019-05-10
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular B-cell non-Hodgkin's lymphoma, Primary central nervous system lymphoma, Marginal zone lymphoma, Diffuse large B-cell lymphoma, Mantle cell lymphoma

Brief summary

AEs including treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, ECG results, ECOG performance status, LVEF assessments, and physical examinations., Recommended Phase 2 Dose (RP2D) and dosing Schedule(s): Dose limiting toxicities (DLTs), and Maximum Tolerated Dose (MTD) during the DLT evaluation period; establish the RP2D and optimal schedule of CC-99282 as monotherapy and in combination with rituximab obinutuzumab, tafasitamab or valemetostat ± rituximab.

Detailed description

Preliminary efficacy: Determined by the Lugano Classification for NHL response criteria including: Objective response rate (ORR), any complete response (CR) or partial response (PR) as best response; Time to response (TTR); Duration of response (DoR); Progression free survival (PFS) and overall survival (OS); Additional DOR, PFS and OS for subjects treated for 6 cycles with CC-99282 + rituximab who discontinue due to achieving CR (Cohort I), Preliminary efficacy in PCNSL: Determined using the modified International PCNSL Collaborative Group (IPCG) criteria including: Objective response rate (ORR); Time to response (TTR); Duration of response (DoR); Progression free survival (PFS) and overall survival (OS)

Interventions

Sponsors

Celgene Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
AEs including treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, ECG results, ECOG performance status, LVEF assessments, and physical examinations., Recommended Phase 2 Dose (RP2D) and dosing Schedule(s): Dose limiting toxicities (DLTs), and Maximum Tolerated Dose (MTD) during the DLT evaluation period; establish the RP2D and optimal schedule of CC-99282 as monotherapy and in combination with rituximab obinutuzumab, tafasitamab or valemetostat ± rituximab.

Secondary

MeasureTime frame
Preliminary efficacy: Determined by the Lugano Classification for NHL response criteria including: Objective response rate (ORR), any complete response (CR) or partial response (PR) as best response; Time to response (TTR); Duration of response (DoR); Progression free survival (PFS) and overall survival (OS); Additional DOR, PFS and OS for subjects treated for 6 cycles with CC-99282 + rituximab who discontinue due to achieving CR (Cohort I), Preliminary efficacy in PCNSL: Determined using the modified International PCNSL Collaborative Group (IPCG) criteria including: Objective response rate (ORR); Time to response (TTR); Duration of response (DoR); Progression free survival (PFS) and overall survival (OS)

Countries

Denmark, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026