Indolent LymphomaNCT07609446
Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma
An observational study of Indolent Lymphoma and Follicular Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma
- What is being tested?
- Pomalidomide
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with indolent B-cell lymphoma
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Haiwen Huang, 0512-80668050, huanghaiwen@suda.edu.cn
About this study
Official title: Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma: A Prospective, Multicenter, Phase II Study
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.
Read more
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
- Being tested
- Pomalidomide
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called Anti-CD20 Monoclonal Antibody, Prednisone
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.
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone | Not described Receives: Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes (3)
complete response rate
Measured: At the end of Cycle 6 (each cycle is 28 days)
progression-free survival
Measured: one-year
overall survival
Measured: one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Indolent LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609446
- Sponsor's protocol ID
- （2026）No. 154
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 27879257Cohen 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.
PubMed 26248505Martin 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.
PubMed 28945884Huntington 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.
PubMed 36810799Walewski 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.
PubMed 31792945Flinn 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.
PubMed 30811293Morschhauser 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.
PubMed 30184451Fowler 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.
PubMed 25439689Morschhauser 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.
PubMed 35947804Jones 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.
PubMed 26913560Lumish 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.
PubMed 33407745
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma: A Prospective, Multicenter, Phase II Study
- ClinicalTrials.gov ID
- NCT07609446
- Acronym / sponsor ID
- （2026）No. 154
- Conditions
- Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Mantle Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone | – | Drug: Pomalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with indolent B-cell lymphoma
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PomalidomideAlso: Anti-CD20 Monoclonal Antibody, PrednisonePomalidomide 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. | Drug | Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone |
Primary outcome
overall response rate
Time frame: At the end of Cycle 6 (each cycle is 28 days)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication: PubMed 27879257Kiesewetter 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.
- Results publication: PubMed 26248505Cohen 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.
- Results publication: PubMed 28945884Martin 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.
- Results publication: PubMed 36810799Huntington 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.
- Results publication: PubMed 31792945Walewski 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.
- Results publication: PubMed 30811293Flinn 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.
- Results publication: PubMed 30184451Morschhauser 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.
- Results publication: PubMed 25439689Fowler 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.
- Results publication: PubMed 35947804Morschhauser 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.
- Results publication: PubMed 26913560Jones 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.
- Results publication: PubMed 33407745Lumish 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indolent Lymphoma and Follicular Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiwen Huang (0512-80668050, huanghaiwen@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: At the end of Cycle 6 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07609446, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.