RecruitingPhase 1

Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma

United States224 participantsStarted 2021-09-15

Plain-language summary

This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is ≥ 18 years of age at the time of signing the informed consent form (ICF).
✓. Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification.
✓. Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI 2-5 in Part 2. For the CELMoD and polatuzumab-R-CHP cohort, the subject must also have IPI score 0 to 5 in Part 2A and IPI 2 to 5 in Part 2B.
✓. Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
✓. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
✓. Participants must have the following laboratory values:
✓. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L in case of documented bone marrow involvement (\> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF)
✓. Hemoglobin (Hb) ≥ 8 g/dL

Exclusion criteria

What they're measuring

Maximum Tolerated Dose (MTD) - Part 1

Timeframe: During the first 2 cycles of treatment (each cycle is 21 days)

Recommended Phase 2 Dose (RP2D) - Part 1

Timeframe: During the first cycle of treatment (each cycle is 21 days)

Safety and tolerability of CC-220 and CC-99282 at RP2D - Part 2

Timeframe: From the first dose of any IP until 28 days after the last dose of IP

Maximum Tolerated Dose (MTD) - Part 2A

Timeframe: During the first cycle of treatment (each cycle is 21 days)

Recommended Phase 2 Dose (RP2D) - Part 2A

Timeframe: During the first cycle of treatment (each cycle is 21 days)

Trial details

NCT IDNCT04884035

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-01

Contact for this trial

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

View on ClinicalTrials.gov More Lymphoma, B-Cell trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is ≥ 18 years of age at the time of signing the informed consent form (ICF).
✓. Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification.
✓. Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI 2-5 in Part 2. For the CELMoD and polatuzumab-R-CHP cohort, the subject must also have IPI score 0 to 5 in Part 2A and IPI 2 to 5 in Part 2B.
✓. Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
✓. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
✓. Participants must have the following laboratory values:
✓. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L in case of documented bone marrow involvement (\> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF)
✓. Hemoglobin (Hb) ≥ 8 g/dL

Exclusion criteria

What they're measuring

Maximum Tolerated Dose (MTD) - Part 1

Timeframe: During the first 2 cycles of treatment (each cycle is 21 days)

Recommended Phase 2 Dose (RP2D) - Part 1

Timeframe: During the first cycle of treatment (each cycle is 21 days)

Safety and tolerability of CC-220 and CC-99282 at RP2D - Part 2

Timeframe: From the first dose of any IP until 28 days after the last dose of IP

Maximum Tolerated Dose (MTD) - Part 2A

Timeframe: During the first cycle of treatment (each cycle is 21 days)

Recommended Phase 2 Dose (RP2D) - Part 2A

Timeframe: During the first cycle of treatment (each cycle is 21 days)