Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Ind… (NCT07441954) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Indolent Lymphoma
53 participantsStarted 2026-03-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
✓. At least one measurable lesion;
✓. Bone marrow hematopoietic function is basically normal. Complete blood count: white blood cell count \>3000/uL, absolute neutrophil count ≥1.5×10\^9/L (use of granulocyte colony-stimulating factor is permitted), platelet count ≥75×10\^9/L (transfusion is allowed to achieve this minimum platelet count), hemoglobin ≥9.0g/dL (prior red blood cell transfusion or use of recombinant human erythropoietin is permitted). If abnormal peripheral blood indices are caused by lymphoma infiltration of bone marrow or spleen, the investigator may exercise discretion in determining eligibility for enrollment.
✓. Normal function of major organs: Liver function: serum bilirubin ≤2.0×ULN, serum ALT and AST ≤2.5×ULN; Renal function: creatinine clearance \>30mL/min;.
✓. The investigator judged that the expected survival period was ≥3 months;
Exclusion criteria
✕. Any other type of lymphoma, including Burkitt lymphoma;
✕. The investigator confirms that the patient may progress to aggressive lymphoma.
✕
What they're measuring
1
Recommended Phase II Dose (RP2D)
Timeframe: day 28 (each cycle is 28 days)
2
Phase 2 : Objective response rate，ORR
Timeframe: Up to the end of 6 cycles of treatment(each cycle is 28 days)
Trial details
NCT IDNCT07441954
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Patients with contraindications or allergies to the investigational drug.
✕. History of VTE or cerebral infarction prior to treatment;.
✕. Patients who have undergone major surgery within 30 days prior to enrollment that may significantly impair physical condition or increase the risk of thrombosis, or who have scheduled surgery during the study period. Subjects planning to undergo minor surgical procedures under local anesthesia that do not significantly affect physical condition or markedly increase thrombosis risk may participate in the study.
✕. Patients with uncontrolled or severe cardiovascular diseases, including myocardial infarction within 3 months prior to enrollment, unstable coronary artery disease, uncontrolled chronic congestive heart failure, Class III-IV heart failure as defined by the New York Heart Association (NYHA), or clinically significant pericardial disease;.