SuspendedPhase 2

Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma

Stopped: sponsor decision

United States37 participantsStarted 2023-06-29

Plain-language summary

This phase II clinical trial evaluates tafasitamab and lenalidomide followed by tafasitamab and the carboplatin, etoposide and ifosfamide (ICE) regimen as salvage therapy for transplant eligible patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide may have antineoplastic activity which may help block the formation of growths that may become cancer. Drugs used in chemotherapy, such as carboplatin, etoposide and ifosfamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tafasitamab and lenalidomide followed by ICE may be a better treatment for patients with relapsed or refractory large B-cell lymphomas.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patient (age 18 or older) * Willing and able to provide written informed consent for the trial, assent when appropriate may be obtained per institutional guidelines * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Considered transplant eligible by the treating physician * Measurable disease by CT (defined as \>= 1.5 cm in diameter) or one or more area of PET avid disease * Have received one line of prior chemo-immunotherapy (i.e. cyclophosphamide, doxorubicin, prednisone, rituximab and vincristine \[R-CHOP\]). Note that corticosteroids for palliation of symptoms and radiation consolidation are not considered a line of therapy for purposes of eligibility determination * Eligible histologic diagnosis includes: Diffuse large B cell lymphoma not otherwise specified (NOS), T cell histiocyte rich large B cell lymphoma, primary mediastinal B Cell lymphoma, follicular lymphoma grade 3B, high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, high grade B cell lymphoma NOS, DLBCL transformed from follicular lymphoma, DLBCL transformed from marginal zone lymphoma, DLBCL leg type, and B cell lymphoma unclassifiable (with features intermediate between DLBCL and classical Hodgkin's lymphoma) * Absolute neutrophil count \>= 1000 / mcL * Platelets \>= 75,000 / mcL in absence of transfusion support within 7 days of determining eligibility * Hemoglobin \>= 8.0 g/dL, with exception of cases in which cytopenias are due to marrow…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is currently listed as 'suspended' — can you find out why it's on hold, whether it's expected to resume, and if so, when that might happen?
2This is a Phase 2 trial testing tafasitamab combined with lenalidomide followed by an ICE chemotherapy regimen as a path toward stem cell transplant — do you think this sequenced approach makes sense for my specific subtype of large B-cell lymphoma compared to standard salvage regimens we already know more about?
3The trial is measuring complete remission rate as its main goal, which means we don't yet have mature data on how long those remissions last or whether they improve survival — how would you weigh that uncertainty against my need to get to transplant quickly?
4Since this trial is designed for people who are eligible for stem cell transplant, how does my current health, organ function, and lymphoma subtype affect whether I'd even be considered a transplant candidate if I responded to this regimen?
5Given that the trial is suspended right now, what alternative salvage therapy options — whether standard of care or other open trials — should we be actively considering so we don't lose time while my lymphoma is active?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete remission (CR) rate

Timeframe: At the end of Cycle (each cycle is 28 days)

Trial details

NCT IDNCT05821088

SponsorDavid Bond, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma trials