An observational study in Indolent Lymphoma, Follicular Lymphoma and Marginal Zone Lymphoma, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by The First Affiliated Hospital of Soochow University · Observational
A Phase II Study of Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma Objective: This prospective, single-arm, Phase II trial aims to evaluate the efficacy and safety of first-line pomalidomide plus anti-CD20 antibody and prednisone in patients with indolent B-cell lymphoma.
Study Population: Approximately 30 adult patients (age ≥18 years) will be enrolled. Eligible histologies include follicular lymphoma (FL), CD20-positive marginal zone lymphoma (MZL: extranodal MALT, splenic SMZL, nodal NMZL), indolent mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and lymphoplasmacytic lymphoma/Waldenström macroglobulinemia. Patients must be treatment-naïve, have an indication for systemic therapy, ECOG performance status 0-2, and adequate bone marrow reserve (ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥9.0 g/dL; lower thresholds permitted if marrow/spleen involvement, per investigator discretion). Adequate organ function is required: bilirubin ≤2×ULN, ALT/AST ≤2.5×ULN, and creatinine clearance >30 mL/min. Life expectancy must be ≥3 months, and written informed consent is mandatory.
Exclusion Criteria: Patients are excluded if they have another malignancy within 5 years (unless curatively treated without recurrence), CNS lymphoma involvement, transformation to high-grade lymphoma, uncontrolled infection, severe comorbidities affecting study participation, significant non-lymphoma-related organ dysfunction (ALT/AST >3×ULN, bilirubin >2×ULN, creatinine >1.5×ULN), active CNS dysfunction, major surgery within 30 days, pregnancy or lactation, lack of contraception in women of childbearing potential, known drug hypersensitivity, or any condition deemed unsuitable by the investigator.
Treatment Regimen: Induction consists of six 28-day cycles. Anti-CD20 antibody is administered at 375 mg/m² weekly during Cycle 1 and on Day 1 of Cycles 2-6. Pomalidomide is given at 4 mg/day on Days 2-22 of Cycles 1-6. Prednisone is administered at 100 mg/day on Days 1-5 of Cycles 1-6. Maintenance therapy continues for 2 years with pomalidomide 4 mg/day on Days 1-14 and anti-CD20 antibody 375 mg/m² on Day 1 every 8 weeks.
Endpoints: The primary endpoint is overall response rate (ORR). Secondary endpoints include complete response rate (CR), progression-free survival (PFS), overall survival (OS), and safety (hematologic and non-hematologic adverse events).
Statistical Methods: Continuous variables will be summarized with descriptive statistics; categorical variables with frequencies and percentages. Time-to-event endpoints (PFS, OS, and duration of response) will be analyzed using the Kaplan-Meier method, reporting medians, quartiles, and 90% confidence intervals, along with event and censoring counts. ORR will be tested statistically and reported with a 90% confidence interval.
Timeline: The study is expected to begin in January 2026, complete enrollment by December 2026, and conclude by December 2027. The total planned sample size is 30 patients.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's planned enrollment of 30 is below the median of 184 across 99 observational studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with indolent B-cell lymphoma
Normal function of major organs:
Exclusion Criteria:
Drug: Pomalidomide
Pomalidomide is given at 4 mg/day on Days 2-22 of Cycles 1-6. Anti-CD20 antibody is administered at 375 mg/m² weekly during Cycle 1 and on Day 1 of Cycles 2-6. Prednisone is administered at 100 mg/day on Days 1-5 of Cycles 1-6.
Also known as: Anti-CD20 Monoclonal Antibody, Prednisone
overall response rate
Time frame: At the end of Cycle 6 (each cycle is 28 days)
complete response rate
Time frame: At the end of Cycle 6 (each cycle is 28 days)
progression-free survival
Time frame: one-year
overall survival
Time frame: one-year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital of Soochow University