RECRUITING

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

Talk to us

Conditions

Follicular LymphomaMarginal Zone Lymphoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-07
Study Completion:2031-07-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06792825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed marginal zone lymphoma
  2. * Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a
  3. * No prior systemic therapy for lymphoma
  4. * Must be in need of treatment as evidenced by one or more of the following criteria:
  5. * Bulky disease defined as:
  6. * a nodal or extranodal (except spleen) mass \>7cm in its greater diameter or,
  7. * involvement of at least 3 nodal or extranodal sites (each with a diameter greater than \>3 cm)
  8. * Presence of at least one of the following B symptoms:
  9. * fever (\>38C) of unclear etiology
  10. * night sweats
  11. * weight loss greater than 10% within the prior 6 months
  12. * Any other symptoms attributable to lymphomatous mass
  13. * Endangerment of vital organ due to lymphomatous mass including but not limited to:
  14. * Symptomatic or massive splenomegaly
  15. * Compression syndrome (including but not limited to ureteral, orbital, gastrointestinal)
  16. * Pleural, pericardial or ascitic effusion regardless of cell count
  17. * Follicular lymphoma in leukemic phase (\>5 X 109/L circulating cells)
  18. * Follicular lymphoma graded high-risk by FLIPI2 score (see Appendix III)
  19. * Adequate organ function within 14 days (28 days for pulmonary or cardiac) of study registration
  20. * 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.
  21. * Able to tolerate prophylactic anticoagulation/antiplatelet therapy while on lenalidomide
  22. * 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)
  1. * Seropositive for or active viral infection with hepatitis B virus (HBV):
  2. * HBV surface antigen (HBsAg) positive
  3. * HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA
  4. * 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).
  5. * Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
  6. * Prior history of lenalidomide use
  7. * Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
  8. * Peripheral neuropathy ≥ grade 2 at time of screening
  9. * Uncontrolled intercurrent illness.
  10. * Active infection (requiring systemic therapy) or has received a live vaccine within 14 days prior to first dose of study drug.
  11. * Presence or history of CNS involvement by lymphoma
  12. * Patients who are not willing to take venous thromboembolic (VTE) prophylaxis or antiplatelet therapy
  13. * Recent ( \<1 year ) arterial thrombosis (any) or venous thrombosis ≥ grade 3 by CTCAE 5.0.
  14. * Pregnant or breastfeeding as agents used in this study are Pregnancy Category X.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-07
Study Completion Date2031-07-08

Study Record Updates

Study Start Date2025-08-07
Study Completion Date2031-07-08

Terms related to this study

Additional Relevant MeSH Terms

  • Follicular Lymphoma
  • Marginal Zone Lymphoma