NCT07441954

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Most indolent B-cell lymphomas have a prolonged natural course with frequent disease relapses, requiring multiple lines of therapy. There is currently no unified standard regimen for relapsed indolent lymphomas, and treatment options are limited for patients who develop resistance to the R2 regimen. Obinutuzumab is a next-generation CD20 monoclonal antibody, while pomalidomide, as a third-generation immunomodulatory drug (IMiDs), exhibits stronger immunomodulatory activity compared to lenalidomide.The Phase I trial evaluated the maximum tolerated dose（MTD） and recommended Phase II dose（RP2D） of the GP regimen (obinutuzumab combined with pomalidomide) in treating relapsed/refractory indolent lymphoma. The Phase II trial assessed the GP regimen, including both induction and maintenance therapy phases, aiming to enhance treatment efficacy, survival rates, and tolerability, thereby providing a novel therapeutic approach for this disease category.

Conditions

• Indolent Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-12-05
• Completion: 2029-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02