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New treatment option for Follicular Lymphoma
Official title HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
ClinicalTrials.gov ID: NCT06792825
What this study is testing
What is Tafasitamab?
Tafasitamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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 people with chronic hepatitis C, or people with an active hepatitis C infection requiring anti-viral medication (at...
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
- Prior history of lenalidomide use
See the full eligibility criteria
- 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,
- 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...
- 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...
- 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 people with chronic hepatitis C, or people 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.