A Phase 2 interventional study of Tafasitamab and Rituximab in Follicular Lymphoma and Marginal Zone Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment
Among 194 studies testing rituximab in Lymphoma, Follicular — 12 open to participants now, 24 under way, 6 of them phase 3. Rituximab · Lymphoma, Follicular.
Among the 194 studies testing rituximab in Lymphoma, Follicular, this one is the 67th largest by planned enrollment of the 188 interventional ones that give a count, is one of 2 that started in 2025, is one of 104 in phase 2, reaches primary completion later than 19 of the 23 other live ones, and was the 191st registered.
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
Browse Lymphoma, Follicular studies →12 of the 194 studies testing rituximab in Lymphoma, Follicular are open now, in 12 countries. Recruiting first, the newest first:
University of Washington · Sites in United States
Paolo Caimi, MD · Sites in United States
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Reid Merryman, MD · Sites in United States
National Cancer Institute (NCI) · Sites in United States
By country, each count listing its studies:
Rituximab: first FDA approval 1997 (RITUXAN), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 226 Lymphoma, Follicular studies recruiting now, 159 (70%) set no upper age limit and 39 (17%) stop at 75 or younger; 33 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
194 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 129 · Phase 3 37
First in 1997; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 65 is above the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.
Median enrollment 48 across the 188 interventional studies. Of the 150 that completed or were terminated, 75 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 194 have an industry lead sponsor. The 10 most frequent:
Masonic Cancer Center, University of Minnesota is the lead sponsor of 286 studies on the registry; 35 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
29 studies in Lymphoma, Follicular by Masonic Cancer Center, University of Minnesota: 4 open now, 4 under way, none of them phase 3. Of 22 finished, 10 (45%) have results posted.
Among the 29 studies in Lymphoma, Follicular by Masonic Cancer Center, University of Minnesota, this one is the 10th largest by planned enrollment of the 28 interventional ones that give a count, is the only one that started in 2025, is one of 15 in phase 2, and was the 29th registered.
Masonic Cancer Center, University of Minnesota’s Lymphoma, Follicular studies by the year they started, since 1999.
5 of the studies testing rituximab in Lymphoma, Follicular that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04224493Phase 3Epizyme, Inc.A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma. | 2027-02-13 |
| NCT01479842Kami Maddocks, MDRituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma | 2026-12-01 |
| NCT06471738Chinese PLA General HospitalCombination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma | 2026-12-30 |
| NCT01473628M.D. Anderson Cancer CenterRadiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma | 2027-05-20 |
| NCT04998669Juan P. Alderuccio, MDLoncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma | 2027-08-01 |
Among the 194 studies testing rituximab in Lymphoma, Follicular, from their registry updates:
Among Masonic Cancer Center, University of Minnesota’s 29 in Lymphoma, Follicular:
This tab as a report to print or save as PDF → With an account.
The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR:
Exclusion Criteria:
Women of must have two negative pregnancy tests (serum or urine) prior to their first dose of lenalidomide, and must agree to scheduled pregnancy testing while on treatment regardless of their choice, per the requirements of the lenalidomide risk evaluation and mitigation strategy (REMS) program.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On Cycle 1, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on Day 1, Day 8, Day 15 and Day 22, and lenalidomide 20 mg PO Day 1 through Day 21. On Cycles 2-3, patients will receive tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on day 1, and lenalidomide 20 mg PO Day 1-21. On Cycles 4-6, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Rituximab 375 mg/m2 IV on Day 1, and lenalidomide 20 mg PO from Day 1-21. At the end of Cycle 6, patients on both cohorts will be assessed by Lugano standard. Patients in complete remission (CR) will continue on tafasitamab/rituximab and discontinue lenalidomide. Patients with partial response (PR) or stable disease (SD) will continue on all three drugs, tafasitamab/rituximab/lenalidomide, and if progressive disease (PD) will discontinue study.
Drug: Tafasitamab · Drug: Rituximab · Drug: Lenalidomide
On Cycle 1, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on Day 1, Day 8, Day 15 and Day 22, and lenalidomide 20 mg PO Day 1 through Day 21. On Cycles 2-3, patients will receive tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on day 1, and lenalidomide 20 mg PO Day 1-21. On Cycles 4-6, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Rituximab 375 mg/m2 IV on Day 1, and lenalidomide 20 mg PO from Day 1-21. At the end of Cycle 6, patients on both cohorts will be assessed by Lugano standard. Patients in complete remission (CR) will continue on tafasitamab/rituximab and discontinue lenalidomide. Patients with partial response (PR) or stable disease (SD) will continue on all three drugs, tafasitamab/rituximab/lenalidomide, and if progressive disease (PD) will discontinue study.
Drug: Tafasitamab · Drug: Rituximab · Drug: Lenalidomide
Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.
Rituximab 375 mg/m2 IV on day 1
Also known as: R2
Lenalidomide 20 mg PO Day 1 through Day 21
Complete response (CR)
Estimate complete response (CR) at the end of study (after 12 cycles around 1 year) regimen of tafasitamab with lenalidomide and rituximab.
Time frame: 1 year
Complete response (CR)
Estimate complete response (CR) rate after 6 cycles of treatment.
Time frame: 6 months
Overall response rate (ORR)
Estimate overall response rate (ORR) at the end of treatment (around 1 year).
Time frame: 1 year
Progression of disease (POD24)
Estimate progression of disease (POD24) within 24 months (2 years)
Time frame: 2 years
Progression free survival (PFS)
Estimate progression free survival (PFS) at 3 years after registration on study
Time frame: 3 years
Overall survival (OS)
Estimate overall survival (OS) at 3 years after registration on study
Time frame: 3 years
Rate of histologic conversion to DLBCL
Estimate rate of histologic conversion to DLBCL at any point on study.
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jul 2029, 47 months after the start.
Of 151 non-industry phase 2 interventional studies under Lymphoma, Follicular, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 110. This study's planned 47 months is below that.
Counting every sponsor, half of 199 studies reached it within 57 months; a quarter within 31 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Tafasitamab · Rituximab · Lenalidomide
Masonic Cancer Center, University of Minnesota →