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NOT YET RECRUITING
NCT07441954
PHASE1/PHASE2

Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Indolent Lymphoma

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

To explore the maximum tolerated dose (MTD) of pomalidomide in combination with obinutuzumab in patients with relapsed/refractory indolent lymphomas (including follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma) treated with the pomalidomide plus obinutuzumab combination regimen, and to determine the recommended phase II dose (RP2D); concurrently evaluating the efficacy and safety of pomalidomide combined with obinutuzumab in patients with relapsed/refractory indolent lymphomas.

Official title: A Prospective, Multicenter, Phase I/II Clinical Study of Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Indolent Lymphoma.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2026-03-20

Completion Date

2029-12-31

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DRUG

Induction therapy of GP(Pomalidomide+Obinutuzumab)

Phase 1: Dose Escalation Phase. Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with a 28-day cycle. Pomalidomide is administered in three dose groups (2 mg, 3 mg, 4 mg) on days 1-21. Dose-limiting toxicity (DLT) is observed during the first cycle to determine the recommended Phase II dose (RP2D). 2、Phase 2: Dose Expansion Phase. Induction Therapy: Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with pomalidomide at RP2D on days 1-21, in 28-day cycles for 6 cycles.

DRUG

maintenance therapy of GP(Pomalidomide+Obinutuzumab)

Maintenance Therapy :Pomalidomide: For complete response (CR) patients, half of the RP2D dose; for PR patients, full RP2D dose, on days 1-21 (Cycles 7-18). Obinutuzumab: 1000 mg administered on day 1 of every 2 cycles