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.
Age ≥18 years old, regardless of gender;
Histopathologically confirmed CD20+ indolent lymphoma (FL, MZL, or SLL), WHO grade 1-3a;.
Relapsed or refractory disease after at least one prior line of therapy;.
ECOG-PS 0-2;
Any other type of lymphoma, including Burkitt lymphoma;
The investigator confirms that the patient may progress to aggressive lymphoma.
Patients with contraindications or allergies to the investigational drug.
History of VTE or cerebral infarction prior to treatment;.
Single group
Induction therapy of GP(Pomalidomide+Obinutuzumab）
DrugPhase 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.
maintenance therapy of GP(Pomalidomide+Obinutuzumab）
DrugMaintenance 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
Recommended Phase II Dose (RP2D)
The drug dose for Phase 2 clinical trials was determined through dose escalation in Phase 1 clinical trials to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
Phase 2 : Objective response rate，ORR
defined as the proportion of patients with complete or partial response as assessed by response to induction therapy.
complete response rate，CRR
progression-free survival，PFS
defined as the time from the start of treatment to disease progression or death due to any cause
Overall survival，OS
Defined as the time from enrollment to death for any cause.
Adverse event rate
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