Classic Follicular LymphomaPhase 2NCT07731789
Tafasitamab and Rituximab for the Treatment of Newly Diagnosed Follicular Lymphoma
A Phase 2 study testing Rituximab, Tafasitamab and Biospecimen Collection in people with Classic Follicular Lymphoma and Grade 1 Follicular Lymphoma, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial tests how well tafasitamab and rituximab works for the treatment of newly diagnosed follicular lymphoma. Tafasitamab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Follicular Lymphoma, Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma
- What is being tested?
- Rituximab, Tafasitamab and Biospecimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2026to 29 Oct 2032
- 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
- Age ≥ 18 years old
- Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma)
- Meeting any one of the following criteria for therapy initiation:
- Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm.
- Any nodal or extranodal tumor mass with a diameter of ≥ 7 cm.
- B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss > 10% within the prior 6 months) attributed to FL.
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- Risk of local compressive symptoms that may result in organ compromise.
- Splenomegaly with the inferior margin below the umbilical line or splenic lesion without splenomegaly.
- Significant cytopenia (absolute neutrophil count < 1500/mm3, platelets < 100,000/uL, hemoglobin < 10 g/dL)
- Leukemia (> 5,0000/uL circulating lymphocytes)
- Pleural effusion or ascites attributed to lymphoma
- Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Absolute neutrophil count ≥ 1500/mm^3 (unless due to lymphoma involvement of the bone marrow or spleen)
- Platelets ≥ 75,000/mm^3 (unless due to bone marrow involvement by lymphoma)
- Hemoglobin ≥ 8 g/dL (unless due to bone marrow involvement by lymphoma)
- Total bilirubin ≤ 2.0 mg/dL, except for patients with documented lymphoma involvement of liver or with a known history of Gilbert's disease
- Alkaline phosphatase/aspartate aminotransferase (AST)/(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ≤ 3 × institutional upper limit of normal, except for patients with documented liver involvement
- Creatinine clearance ≥ 30 ml/min
- Fertile male and women of child bearing potential (WOCBP) patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the last dose of study treatment
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- FL grade 3B or transformed FL
- Patients receiving any other investigational agents
- Patients with known central nervous system involvement of lymphoma
- History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the primary investigator (PI) may be included
- Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
- Uncontrolled intercurrent illness such as: history of myocardial infarction (MI) in the last 6 months, congestive heart failure New York Heart Association (NYHA) Class III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver cirrhosis, and autoimmune disorder requiring immunosuppression or long-term corticosteroids (> 10 mg daily prednisone equivalent)
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- Prior use of any monoclonal antibody within 4 weeks before the first administration
- Breastfeeding or pregnant women
- Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody are eligible if the corresponding polymerase chain reaction (PCR) test is negative prior to enrollment. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis as per institutional guidelines
- History of human immunodeficiency virus (HIV) infection uncles the viral load is undetectable and CD4 count is at least 400
- History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Major surgery (excluding lymph node biopsy) within 28 days prior to signing the informed consent form (ICF) unless the participant is recovered at the time of signing the ICF
- Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of cycle 1
- Administration of a live vaccine within 28 days prior to the start of study treatment (cycle 1 day 1)
- History of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory drugs, rituximab, other monocolonal antibodies (mAbs), and/or the excipients contained in the study drug formulations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Mengyang Di, MD, PhD, 206-606-2519, mydi@fredhutch.org
Mengyang Di, MD, PhD
About this study
Official title: TREND-FL: Tafasitamab and Rituximab to Enhance Outcomes in Patients With Newly Diagnosed Follicular Lymphoma
This phase II trial tests how well tafasitamab and rituximab works for the treatment of newly diagnosed follicular lymphoma. Tafasitamab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving tadasitamab and rituximab may work well to treat patients with newly diagnosed follicular lymphoma.
Read the detailed description
OUTLINE:
CYCLES 1-3: Patients receive rituximab intravenously (IV) on day 1 and tafasitamab IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
CYCLES 4-6; Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12.
CYCLES 7-12: Patients receive tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, bone marrow biopsy and aspiration and blood sample collection throughout the study.
After completion of study treatment, patients are followed up periodically for up to 5 years.
- Conditions
- Classic Follicular Lymphoma, Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma, Grade 3a Follicular Lymphoma
- Being tested
- Rituximab, Tafasitamab, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabBiological
Also called ABP 798, ABP-798, ABP798, BI 695500
Given IV
TafasitamabBiological
Also called Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR 00208, MOR 208
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan
Undergo PET scan
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Tafasitamab and rituximab) | Experimental | CYCLES 1-3: Patients receive rituximab IV on day 1 and tafasitamab IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
CYCLES 4-6; Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12.
CYCLES 7-12: Patients receive tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo PET scan, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study. Receives: Biological: Rituximab; Biological: Tafasitamab; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission at the best response
Assessed by positron emission tomography (PET)/computed tomography (CT) and diagnostic CT scans based on Lugano criteria. Will report the number of complete response (CR) at the best response within one year of starting study treatment and the estimated CR rate with 95% exact binomial confidence interval (CI).
Measured: Up to 1 year of starting treatment
Secondary outcomes (6)
Incidence of adverse events (AEs)
Defined as the incidence and severity of each AE graded based on Common Terminology Criteria for Adverse Events, among patients who receive at least one dose of tafasitamab. Will report the count, percentage, and 95% exact binomial CI.
Measured: Up to 30 days after completing the last dose of study treatment
Overall response at the best response
Among response evaluable patients, the overall response including complete remission and partial response at the best response assessed by PET/CT and diagnostic CT scans based on Lugano criteria.
Measured: Up to 1 year of starting treatment
Complete remission
Defined as complete remission after cycle 6 of rituximab and tafasitamab, assessed by PET/CT and diagnostic CT scans, based on Lugano criteria.
Measured: After cycle 6 (cycle length =28 days)
Progression free survival (PFS)
Will apply Kaplan-Meier method to estimate the survival rate. Will report 12-month and 24-month PFS rates with 95% CI.
Measured: From cycle 1 day 1 to disease progression or death, up to 5 years
Overall survival (OS)
Will apply Kaplan-Meier method to estimate the survival rate. Will report 12-month and 24-month OS rates with 95% CI.
Measured: From cycle 1 day 1 to death regardless of the causes of death, up to 5 years
Duration of response
Will apply Kaplan-Meier method to estimate the survival rate.
Measured: From first partial response or complete response to progression of disease or death, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start9 Oct 2026
- Primary completion31 Oct 2030 (estimated)
- Study completion29 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Mengyang Di, MD, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731789
- Sponsor's protocol ID
- RG1126498
- Other IDs
- NCI-2026-04963, FHIRB0021369
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREND-FL: Tafasitamab and Rituximab to Enhance Outcomes in Patients With Newly Diagnosed Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT07731789
- Acronym / sponsor ID
- RG1126498
- Conditions
- Classic Follicular Lymphoma, Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma, Grade 3a Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 29 Oct 2032 (estimated)
- First posted
- 28 Jul 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.
This phase II trial tests how well tafasitamab and rituximab works for the treatment of newly diagnosed follicular lymphoma. Tafasitamab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving tadasitamab and rituximab may work well to treat patients with newly diagnosed follicular lymphoma.
Detailed description
OUTLINE:
CYCLES 1-3: Patients receive rituximab intravenously (IV) on day 1 and tafasitamab IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
CYCLES 4-6; Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12.
CYCLES 7-12: Patients receive tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, bone marrow biopsy and aspiration and blood sample collection throughout the study.
After completion of study treatment, patients are followed up periodically for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Tafasitamab and rituximab) | Experimental | Biological: Rituximab, Biological: Tafasitamab, Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Survey AdministrationCYCLES 1-3: Patients receive rituximab IV on day 1 and tafasitamab IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. CYCLES 4-6; Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12. CYCLES 7-12: Patients receive tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years old
- Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma)
- Meeting any one of the following criteria for therapy initiation:
- Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (15 listed)
- FL grade 3B or transformed FL
- Patients receiving any other investigational agents
- Patients with known central nervous system involvement of lymphoma
- History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the primary investigator (PI) may be included
- Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
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 |
|---|---|---|
| RituximabAlso: ABP 798, ABP-798, ABP798, BI 695500Given IV | Biological | Treatment (Tafasitamab and rituximab) |
| TafasitamabAlso: Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR 00208, MOR 208Given IV | Biological | Treatment (Tafasitamab and rituximab) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (Tafasitamab and rituximab) |
| Bone Marrow AspirationUndergo bone marrow aspiration | Procedure or surgery | Treatment (Tafasitamab and rituximab) |
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, Biopsy, Bone MarrowUndergo bone marrow biopsy | Procedure or surgery | Treatment (Tafasitamab and rituximab) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Treatment (Tafasitamab and rituximab) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography ScanUndergo PET scan | Procedure or surgery | Treatment (Tafasitamab and rituximab) |
| Survey AdministrationAncillary studies | Other | Treatment (Tafasitamab and rituximab) |
Primary outcome
Complete remission at the best response
Time frame: Up to 1 year of starting treatment
Assessed by positron emission tomography (PET)/computed tomography (CT) and diagnostic CT scans based on Lugano criteria. Will report the number of complete response (CR) at the best response within one year of starting study treatment and the estimated CR rate with 95% exact binomial confidence interval (CI).
6 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 30 days after completing the last dose of study treatment
Overall response at the best response
Time frame: Up to 1 year of starting treatment
Complete remission
Time frame: After cycle 6 (cycle length =28 days)
Progression free survival (PFS)
Time frame: From cycle 1 day 1 to disease progression or death, up to 5 years
Overall survival (OS)
Time frame: From cycle 1 day 1 to death regardless of the causes of death, up to 5 years
Duration of response
Time frame: From first partial response or complete response to progression of disease or death, up to 5 years
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Mengyang Di, MD, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Tafasitamab and Biospecimen Collection in people with Classic Follicular Lymphoma and Grade 1 Follicular Lymphoma, run by University of Washington 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 21 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 15 Oct 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 Mengyang Di, MD, PhD (206-606-2519, mydi@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission at the best response (time frame: Up to 1 year of starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.