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Follicular LymphomaPhase 2NCT06792825

HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL

A Phase 2 study testing Tafasitamab, Rituximab and Lenalidomide in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma, Marginal Zone Lymphoma
What is being tested?
Tafasitamab, Rituximab and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
7 Aug 2025to 8 Jul 2031
Phase
Phase 2
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

Who may be able to join

  • Histologically confirmed marginal zone lymphoma
  • Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a
  • No prior systemic therapy for lymphoma
  • Must be in need of treatment as evidenced by one or more of the following criteria:
  • Bulky disease defined as:
  • a nodal or extranodal (except spleen) mass >7cm in its greater diameter or,
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  • involvement of at least 3 nodal or extranodal sites (each with a diameter greater than >3 cm)
  • Presence of at least one of the following B symptoms:
  • fever (>38C) of unclear etiology
  • night sweats
  • weight loss greater than 10% within the prior 6 months
  • Any other symptoms attributable to lymphomatous mass
  • Endangerment of vital organ due to lymphomatous mass including but not limited to:
  • Symptomatic or massive splenomegaly
  • Compression syndrome (including but not limited to ureteral, orbital, gastrointestinal)
  • Pleural, pericardial or ascitic effusion regardless of cell count
  • Follicular lymphoma in leukemic phase (>5 X 109/L circulating cells)
  • OR:
  • Follicular lymphoma graded high-risk by FLIPI2 score (see Appendix III)
  • Adequate organ function within 14 days (28 days for pulmonary or cardiac) of study registration
  • Participants who are of childbearing potential or have partners of child-bearing potential must agree to either total abstinence or use of both a highly effective (IUD, hormonal contraceptives, tubal ligation or vasectomy), and effective contraception (male or female condom, diaphragm or cervical cap) for the duration of treatment and for 12 months after the last dose of study drug.
  • Able to tolerate prophylactic anticoagulation/antiplatelet therapy while on lenalidomide
  • Able to provide written voluntary consent prior to the performance of any research related tests or procedures (or the subject's legally authorized representative (LAR) if enrollment of persons with diminished capacity is permitted - general permitted for Phase II and greater studies)

Who cannot join

  • Seropositive for or active viral infection with hepatitis B virus (HBV):
  • HBV surface antigen (HBsAg) positive
  • HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA
  • Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an active hepatitis C infection requiring anti-viral medication (at time of randomization).
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
  • Prior history of lenalidomide use
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  • Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
  • Peripheral neuropathy ≥ grade 2 at time of screening
  • Uncontrolled intercurrent illness.
  • Active infection (requiring systemic therapy) or has received a live vaccine within 14 days prior to first dose of study drug.
  • Presence or history of CNS involvement by lymphoma
  • Patients who are not willing to take venous thromboembolic (VTE) prophylaxis or antiplatelet therapy
  • Recent ( <1 year ) arterial thrombosis (any) or venous thrombosis ≥ grade 3 by CTCAE 5.0.
  • Pregnant or breastfeeding as agents used in this study are Pregnancy Category X.
  • Women of childbearing potential 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 birth control choice, per the requirements of the lenalidomide risk evaluation and mitigation strategy (REMS) program.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sanjal Desai, MD contact

612-624-9452

desai171@umn.edu

United States1 site, 1 recruiting

  • Masonic Cancer Center

    Minneapolis, Minnesota, 55455

    Sanjal Desai, MD, 612-624-9452, desai171@umn.edu

    Recruiting

Other trials in United States

About this study

Official title: HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

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.

Being tested
Tafasitamab, Rituximab, Lenalidomide
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.

  • TafasitamabDrug

    Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.

  • RituximabDrug

    Also called R2

    Rituximab 375 mg/m2 IV on day 1

  • LenalidomideDrug

    Lenalidomide 20 mg PO Day 1 through Day 21

Study groups in NCT06792825
Study groupRoleWhat they receive
Follicular LymphomaExperimentalOn 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.
Receives: Drug: Tafasitamab; Drug: Rituximab; Drug: Lenalidomide
Marginal Zone LymphomaExperimentalOn 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.
Receives: Drug: Tafasitamab; Drug: Rituximab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (6)

  1. Complete response (CR)

    Estimate complete response (CR) rate after 6 cycles of treatment.

    Measured: 6 months

  2. Overall response rate (ORR)

    Estimate overall response rate (ORR) at the end of treatment (around 1 year).

    Measured: 1 year

  3. Progression of disease (POD24)

    Estimate progression of disease (POD24) within 24 months (2 years)

    Measured: 2 years

  4. Progression free survival (PFS)

    Estimate progression free survival (PFS) at 3 years after registration on study

    Measured: 3 years

  5. Overall survival (OS)

    Estimate overall survival (OS) at 3 years after registration on study

    Measured: 3 years

  6. Rate of histologic conversion to DLBCL

    Estimate rate of histologic conversion to DLBCL at any point on study.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start7 Aug 2025
  3. Primary completion8 Jul 2029 (estimated)
  4. Study completion8 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06792825
Sponsor's protocol ID
2023LS183
Status last verified
Aug 2026
First submitted
23 Jan 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafasitamab, Rituximab and Lenalidomide in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

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 23 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 12 Aug 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Sanjal Desai, MD (612-624-9452, desai171@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) (time frame: 1 year). 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 NCT06792825.

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 12 Aug 2026.

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