[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731789":3,"trial-entities:NCT07731789":263,"trial-summary:NCT07731789":267},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":163,"secondary_outcomes":168,"sex":192,"minimum_age":193,"maximum_age":194,"healthy_volunteers":195,"eligibility_criteria":196,"std_ages":236,"locations":239,"central_contacts":257,"overall_officials":259,"references":261,"see_also_links":262},"NCT07731789","RG1126498","Tafasitamab and Rituximab for the Treatment of Newly Diagnosed Follicular Lymphoma","TREND-FL: Tafasitamab and Rituximab to Enhance Outcomes in Patients With Newly Diagnosed Follicular Lymphoma","NOT_YET_RECRUITING","2032-10-29","2026-07","2026-07-28","2026-10-31","University of Washington","OTHER",true,"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.","OUTLINE:\n\nCYCLES 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.\n\nCYCLES 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.\n\nPatients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12.\n\nCYCLES 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.\n\nPatients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, bone marrow biopsy and aspiration and blood sample collection throughout the study.\n\nAfter completion of study treatment, patients are followed up periodically for up to 5 years.",[19,20,21,22],"Classic Follicular Lymphoma","Grade 1 Follicular Lymphoma","Grade 2 Follicular Lymphoma","Grade 3a Follicular Lymphoma",[],"INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},30,"ESTIMATED",[32,98,113,123,127,134,149,159],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"BIOLOGICAL","Rituximab","Given IV",[37],"Treatment (Tafasitamab and rituximab)",[39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"ABP 798","ABP-798","ABP798","BI 695500","BI-695500","BI695500","Blitzima","C2B8 Monoclonal Antibody","Chimeric Anti-CD20 Antibody","CT P10","CT-P10","CTP10","GP 2013","GP-2013","GP2013","IDEC 102","IDEC-102","IDEC-C2B8","IDEC-C2B8 Monoclonal Antibody","IDEC102","Ikgdar","Mabtas","MabThera","Monoclonal Antibody IDEC-C2B8","PF 05280586","PF-05280586","PF05280586","Riabni","Ritemvia","Rituxan","Rituximab ABBS","Rituximab ARRX","Rituximab Biosimilar ABP 798","Rituximab Biosimilar BI 695500","Rituximab Biosimilar CT-P10","Rituximab Biosimilar GB241","Rituximab Biosimilar GP2013","Rituximab Biosimilar IBI301","Rituximab Biosimilar JHL1101","Rituximab Biosimilar PF-05280586","Rituximab Biosimilar RTXM83","Rituximab Biosimilar SAIT101","Rituximab Biosimilar SIBP-02","rituximab biosimilar TQB2303","Rituximab PVVR","Rituximab-abbs","Rituximab-arrx","Rituximab-blit","Rituximab-pvvr","Rituximab-rite","Rituximab-rixa","Rituximab-rixi","Rixathon","Riximyo","RTXM 83","RTXM-83","RTXM83","Ruxience","Truxima",{"type":33,"name":99,"description":35,"armGroupLabels":100,"otherNames":101},"Tafasitamab",[37],[102,103,104,105,106,107,108,109,110,111,112],"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","MOR-00208","MOR-208","MOR00208","MOR208","Tafasitamab-cxix","XmAb-5574","XmAb5574",{"type":114,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[37],[119,120,121,122],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":114,"name":124,"description":125,"armGroupLabels":126},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[37],{"type":114,"name":128,"description":129,"armGroupLabels":130,"otherNames":131},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[37],[132,133],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":114,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Computed Tomography","Undergo CT scan",[37],[139,140,141,142,143,144,145,146,147,148],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan",{"type":114,"name":150,"description":151,"armGroupLabels":152,"otherNames":153},"Positron Emission Tomography","Undergo PET scan",[37],[154,155,156,157,158],"Medical Imaging, Positron Emission Tomography","PET","PET scan","Positron Emission Tomography Scan","Positron-Emission Tomography",{"type":14,"name":160,"description":161,"armGroupLabels":162},"Survey Administration","Ancillary studies",[37],[164],{"measure":165,"description":166,"timeFrame":167},"Complete remission at the best response","Assessed by positron emission tomography (PET)\u002Fcomputed 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).","Up to 1 year of starting treatment",[169,173,176,180,184,188],{"measure":170,"description":171,"timeFrame":172},"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.","Up to 30 days after completing the last dose of study treatment",{"measure":174,"description":175,"timeFrame":167},"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\u002FCT and diagnostic CT scans based on Lugano criteria.",{"measure":177,"description":178,"timeFrame":179},"Complete remission","Defined as complete remission after cycle 6 of rituximab and tafasitamab, assessed by PET\u002FCT and diagnostic CT scans, based on Lugano criteria.","After cycle 6 (cycle length =28 days)",{"measure":181,"description":182,"timeFrame":183},"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.","From cycle 1 day 1 to disease progression or death, up to 5 years",{"measure":185,"description":186,"timeFrame":187},"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.","From cycle 1 day 1 to death regardless of the causes of death, up to 5 years",{"measure":189,"description":190,"timeFrame":191},"Duration of response","Will apply Kaplan-Meier method to estimate the survival rate.","From first partial response or complete response to progression of disease or death, up to 5 years","ALL","18 Years",null,false,{"inclusion":197,"exclusion":219,"raw_text":235},[198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218],"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.","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 \\\u003C 1500\u002Fmm3, platelets \\\u003C 100,000\u002FuL, hemoglobin \\\u003C 10 g\u002FdL)","Leukemia (\\> 5,0000\u002FuL 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\u002Fmm\\^3 (unless due to lymphoma involvement of the bone marrow or spleen)","Platelets ≥ 75,000\u002Fmm\\^3 (unless due to bone marrow involvement by lymphoma)","Hemoglobin ≥ 8 g\u002FdL (unless due to bone marrow involvement by lymphoma)","Total bilirubin ≤ 2.0 mg\u002FdL, except for patients with documented lymphoma involvement of liver or with a known history of Gilbert's disease","Alkaline phosphatase\u002Faspartate aminotransferase (AST)\u002F(serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional upper limit of normal, except for patients with documented liver involvement","Creatinine clearance ≥ 30 ml\u002Fmin","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",[220,221,222,223,224,225,226,227,228,229,230,231,232,233,234],"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)","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\u002For 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\u002For the excipients contained in the study drug formulations","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma)\n* Meeting any one of the following criteria for therapy initiation:\n\n  * Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm.\n  * Any nodal or extranodal tumor mass with a diameter of ≥ 7 cm.\n  * B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \\> 10% within the prior 6 months) attributed to FL.\n  * Risk of local compressive symptoms that may result in organ compromise.\n  * Splenomegaly with the inferior margin below the umbilical line or splenic lesion without splenomegaly.\n  * Significant cytopenia (absolute neutrophil count \\\u003C 1500\u002Fmm3, platelets \\\u003C 100,000\u002FuL, hemoglobin \\\u003C 10 g\u002FdL)\n  * Leukemia (\\> 5,0000\u002FuL circulating lymphocytes)\n  * Pleural effusion or ascites attributed to lymphoma\n* 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\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count ≥ 1500\u002Fmm\\^3 (unless due to lymphoma involvement of the bone marrow or spleen)\n* Platelets ≥ 75,000\u002Fmm\\^3 (unless due to bone marrow involvement by lymphoma)\n* Hemoglobin ≥ 8 g\u002FdL (unless due to bone marrow involvement by lymphoma)\n* Total bilirubin ≤ 2.0 mg\u002FdL, except for patients with documented lymphoma involvement of liver or with a known history of Gilbert's disease\n* Alkaline phosphatase\u002Faspartate aminotransferase (AST)\u002F(serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional upper limit of normal, except for patients with documented liver involvement\n* Creatinine clearance ≥ 30 ml\u002Fmin\n* 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\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* FL grade 3B or transformed FL\n* Patients receiving any other investigational agents\n* Patients with known central nervous system involvement of lymphoma\n* 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\n* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment\n* 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)\n* Prior use of any monoclonal antibody within 4 weeks before the first administration\n* Breastfeeding or pregnant women\n* 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\n* History of human immunodeficiency virus (HIV) infection uncles the viral load is undetectable and CD4 count is at least 400\n* History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n* 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\n* Any systemic anti-lymphoma and\u002For investigational therapy within 28 days prior to the start of cycle 1\n* Administration of a live vaccine within 28 days prior to the start of study treatment (cycle 1 day 1)\n* History of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory drugs, rituximab, other monocolonal antibodies (mAbs), and\u002For the excipients contained in the study drug formulations",[237,238],"ADULT","OLDER_ADULT",[240],{"facility":241,"city":242,"state":243,"zip":244,"country":245,"contacts":246,"geoPoint":254},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[247,252],{"name":248,"role":249,"phone":250,"email":251},"Mengyang Di, MD, PhD","CONTACT","206-606-2519","mydi@fredhutch.org",{"name":248,"role":253},"PRINCIPAL_INVESTIGATOR",{"lat":255,"lon":256},47.60621,-122.33207,[258],{"name":248,"role":249,"phone":250,"email":251},[260],{"name":248,"affiliation":241,"role":253},[],[],{"nct_id":4,"conditions":264,"biomarkers":265},[19,20,21,22],[266],"MS4A1 Gene",{"nct_id":4,"found":15,"summary":268,"prompt_version":278},{"design":269,"status":270,"heading":271,"summary":272,"follow_up":273,"word_count":274,"commitments":275,"compensation":276,"drugs_mentioned":277},"This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 30 participants.","completed","Tafasitamab and Rituximab for Newly Diagnosed Follicular Lymphoma","This study is testing how well two medicines, tafasitamab and rituximab, work together to treat newly diagnosed follicular lymphoma. Follicular lymphoma is a type of cancer that affects white blood cells. Both tafasitamab and rituximab are monoclonal antibodies, which are proteins that can help your immune system fight cancer cells. The study aims to see how many patients achieve complete remission (meaning the cancer is no longer detectable) within one year of starting treatment. You may be able to join if you are 18 or older, have a confirmed diagnosis of follicular lymphoma (grades 1, 2, 3A, or classic), and meet specific criteria for needing treatment, such as having large tumors or many affected lymph nodes. The current status of this study is unclear, and it plans to enroll 30 participants.","After completing treatment, patients will be followed periodically for up to 5 years.",131,"You would receive rituximab and tafasitamab intravenously (through a vein) over several cycles. You would also undergo blood sample collection, bone marrow aspiration, bone marrow biopsy, PET scans, and CT scans throughout the study.","Not stated in the trial record.",[34,99],"v2"]