Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma

NCT07609446 | Not Yet Recruiting

• 1 other identifier: （2026）No. 154
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Indolent Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Indolent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• overall response rate

  At the end of Cycle 6 (each cycle is 28 days)

Secondary Outcomes (3)

• complete response rate

  At the end of Cycle 6 (each cycle is 28 days)

• progression-free survival

  one-year

• overall survival

  one-year

Study Arms (1)

Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone

Drug: Pomalidomide

Interventions

Pomalidomide DRUG

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

Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with indolent B-cell lymphoma

You may qualify if:

• Age ≥ 18 years, regardless of sex;
• Confirmed diagnosis of follicular lymphoma (FL), or histopathologically confirmed CD20-positive marginal zone lymphoma (MZL), including extranodal marginal zone lymphoma (MALT), splenic marginal zone lymphoma (SMZL), and nodal marginal zone lymphoma (NMZL),or confirmed diagnosis of indolent mantle cell lymphoma (MCL);
• Patients with a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL);
• Confirmed diagnosis of lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia;
• Presence of indications for treatment of indolent B-cell lymphoma;
• No prior systemic antitumor therapy for lymphoma;
• ECOG-PS score 0-2;
• Essentially normal bone marrow hematopoietic function, with routine blood tests as follows: white blood cell count \>3000/uL, absolute neutrophil count ≥1.5 × 10\^9/L (use of granulocyte colony-stimulating factor is allowed), platelet count ≥75 × 10\^9/L (transfusion to reach this minimum platelet count is allowed), and hemoglobin ≥9.0 g/dL (prior red blood cell transfusion or use of recombinant human erythropoietin is allowed). If peripheral blood abnormalities are caused by lymphoma involvement of the bone marrow or spleen, neutrophils≥1.0 × 10\^9/L and platelets≥50 × 10\^9/L are acceptable (the investigator may determine at his/her discretion whether enrollment is appropriate);
• Normal function of major organs:
• Hepatic function: serum bilirubin ≤2.0 × ULN; serum ALT and AST ≤2.5 × ULN;
• Renal function: creatinine clearance \>30 mL/min;
• Expected survival≥3 months as judged by the investigator; Voluntary written informed consent signed before trial screening;

You may not qualify if:

• Current or prior other malignancy, unless curative treatment has been performed and there has been no evidence of recurrence or metastasis within the past 5 years;
• Lymphoma involvement of the central nervous system or transformation to a higher-grade lymphoma;
• Hepatic or renal dysfunction unrelated to lymphoma: alanine aminotransferase (ALT) \>3 times the upper limit of normal, aspartate aminotransferase (AST) \>3 times the upper limit of normal, total bilirubin (TBIL) \>2 times the upper limit of normal, or serum creatinine \>1.5 times the upper limit of normal;
• Other serious medical conditions that would affect this study (e.g., uncontrolled diabetes, gastric ulcer, or other serious cardiopulmonary diseases). The investigator has the authority to make this determination;
• Severe or uncontrolled infection;
• Clinically manifest central nervous system dysfunction;
• Major surgery within the past 30 days (excluding lymph node biopsy);
• Pregnant or lactating women, or women of childbearing potential who have not used contraceptive measures;
• Allergy to the study drug; Patients considered unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Related Publications (11)

• Kiesewetter B, Willenbacher E, Willenbacher W, Egle A, Neumeister P, Voskova D, Mayerhoefer ME, Simonitsch-Klupp I, Melchardt T, Greil R, Raderer M; AGMT Investigators. A phase 2 study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma. Blood. 2017 Jan 19;129(3):383-385. doi: 10.1182/blood-2016-06-720599. Epub 2016 Nov 22. No abstract available.

  PMID: 27879257 RESULT

• Cohen JB, Switchenko JM, Koff JL, Sinha R, Kaufman JL, Khoury HJ, Bumpers N, Colbert A, Hutchison-Rzepka A, Nastoupil LJ, Heffner LT, Langston AA, Lechowicz MJ, Lonial S, Flowers CR. A phase II study of bortezomib added to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated indolent non-Hodgkin's lymphoma. Br J Haematol. 2015 Nov;171(4):539-46. doi: 10.1111/bjh.13637. Epub 2015 Aug 7.

  PMID: 26248505 RESULT

• Martin P, Jung SH, Pitcher B, Bartlett NL, Blum KA, Shea T, Hsi ED, Ruan J, Smith SE, Leonard JP, Cheson BD. A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL): CALGB 50803 (Alliance). Ann Oncol. 2017 Nov 1;28(11):2806-2812. doi: 10.1093/annonc/mdx496.

  PMID: 28945884 RESULT

• Huntington SF, Schuster SJ, Ding W, Koehler AB, Brander DM, Rosenthal AC, Leis JF, Tun HW, Moustafa MA, Iqbal M, He W, Kearney AS, McKinlay TP, Gui M, Mato AR. DTRMWXHS-12, a novel Bruton tyrosine kinase inhibitor, in combination with everolimus and pomalidomide in patients with relapsed/refractory lymphomas: An open-label, multicenter, phase 1a/1b study. Am J Hematol. 2023 May;98(5):739-749. doi: 10.1002/ajh.26888. Epub 2023 Mar 7.

  PMID: 36810799 RESULT

• Walewski J, Paszkiewicz-Kozik E, Michalski W, Rymkiewicz G, Szpila T, Butrym A, Giza A, Zaucha JM, Kalinka-Warzocha E, Wieczorkiewicz A, Zimowska-Curylo D, Knopinska-Posluszny W, Tyczynska A, Romejko-Jarosinska J, Dabrowska-Iwanicka A, Gruszecka B, Jamrozek-Jedlinska M, Borawska A, Holda W, Porowska A, Romanowicz A, Hellmann A, Stella-Holowiecka B, Deptala A, Jurczak W. First-line R-CVP versus R-CHOP induction immunochemotherapy for indolent lymphoma with rituximab maintenance. A multicentre, phase III randomized study by the Polish Lymphoma Research Group PLRG4. Br J Haematol. 2020 Mar;188(6):898-906. doi: 10.1111/bjh.16264. Epub 2019 Dec 2.

  PMID: 31792945 RESULT

• Flinn IW, van der Jagt R, Kahl B, Wood P, Hawkins T, MacDonald D, Simpson D, Kolibaba K, Issa S, Chang J, Trotman J, Hallman D, Chen L, Burke JM. First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study. J Clin Oncol. 2019 Apr 20;37(12):984-991. doi: 10.1200/JCO.18.00605. Epub 2019 Feb 27.

  PMID: 30811293 RESULT

• Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

  PMID: 30184451 RESULT

• Fowler NH, Davis RE, Rawal S, Nastoupil L, Hagemeister FB, McLaughlin P, Kwak LW, Romaguera JE, Fanale MA, Fayad LE, Westin JR, Shah J, Orlowski RZ, Wang M, Turturro F, Oki Y, Claret LC, Feng L, Baladandayuthapani V, Muzzafar T, Tsai KY, Samaniego F, Neelapu SS. Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial. Lancet Oncol. 2014 Nov;15(12):1311-8. doi: 10.1016/S1470-2045(14)70455-3. Epub 2014 Oct 15.

  PMID: 25439689 RESULT

• Morschhauser F, Nastoupil L, Feugier P, Schiano de Colella JM, Tilly H, Palomba ML, Bachy E, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Le Gouill S, Daguindau N, Guidez S, Pica GM, Garcia-Sancho AM, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Kalung W, Sehn LH, Izutsu K, Cartron G, Gkasiamis A, Crowe R, Xerri L, Fowler NH, Salles G. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022 Oct 1;40(28):3239-3245. doi: 10.1200/JCO.22.00843. Epub 2022 Aug 10.

  PMID: 35947804 RESULT

• Jones JR, Pawlyn C, Davies FE, Morgan GJ. The safety of pomalidomide for the treatment of multiple myeloma. Expert Opin Drug Saf. 2016;15(4):535-47. doi: 10.1517/14740338.2016.1154039. Epub 2016 Mar 16.

  PMID: 26913560 RESULT

• Lumish M, Falchi L, Imber BS, Scordo M, von Keudell G, Joffe E. How we treat mature B-cell neoplasms (indolent B-cell lymphomas). J Hematol Oncol. 2021 Jan 6;14(1):5. doi: 10.1186/s13045-020-01018-6.

  PMID: 33407745 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone

Interventions

pomalidomide; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Haiwen Huang

CONTACT

0512-80668050; huanghaiwen@suda.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)