Study on Tafasitamab and Lenalidomide Followed by ICE Chemotherapy for Patients with Relapsed or Hard-to-Treat Large B-Cell Lymphoma Eligible for Transplant

Sponsor: David Bond, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05821088

Provider View

This clinical trial is testing a new treatment approach for patients with large B-cell lymphoma that has returned or not responded to previous treatments. The study combines the drugs tafasitamab and lenalidomide with a chemotherapy regimen called ICE, to see if this combination is more effective for patients who are eligible for a stem cell transplant.

Patient Parameters

Program Overview

This phase II study is exploring whether a combination of tafasitamab and lenalidomide, followed by tafasitamab and a chemotherapy regimen called ICE, can be an effective treatment for patients with large B-cell lymphoma that has come back or not responded to previous treatments. Tafasitamab is a type of drug that may help stop cancer cells from growing and spreading. Lenalidomide may help block the formation of cancerous growths. The chemotherapy drugs carboplatin, etoposide, and ifosfamide work in different ways to stop cancer cells from growing, dividing, or spreading. This study aims to find out if this combination can be a better option for patients eligible for a stem cell transplant.

Description

Primary Objective:

  • To assess how well the combination of tafasitamab and lenalidomide, followed by tafasitamab and ICE chemotherapy, works as a first salvage treatment for patients with relapsed or refractory large B-cell lymphoma, by measuring the complete response rate after 2 or 4 cycles of treatment.

Secondary Objectives:

  • To evaluate the overall response rate to the treatment combination in patients eligible for a transplant after 2-4 cycles.
  • To assess the response rate to tafasitamab and lenalidomide alone after two cycles.
  • To determine the success rate of stem cell mobilization after treatment.
  • To evaluate the success rate of completing a stem cell transplant after treatment.
  • To monitor the side effects according to standard criteria.
  • To assess progression-free and overall survival rates in the study group.
  • To compare long-term outcomes between patients who proceed to transplant after 2 cycles versus those who complete 4 cycles followed by ICE.

Exploratory Objectives:

  • To evaluate the response to further anti-CD19 CAR-T treatment in patients who need additional therapy.
  • To assess CD19 expression in patients with further relapse or refractory disease.
  • To explore the relationship between clinical outcomes and tumor characteristics.
  • To examine the link between circulating tumor DNA clearance and clinical outcomes.
  • To evaluate the association between clinical outcomes and the duration of response to first-line therapy.

Study Outline:

Participants will receive tafasitamab intravenously, lenalidomide orally, and the chemotherapy drugs etoposide, ifosfamide, and carboplatin intravenously. They will undergo imaging scans and blood tests throughout the study, and may have a tissue biopsy.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Able to provide written consent for the trial.
  • Good overall health with a performance status score of 0 to 2.
  • Eligible for a stem cell transplant as determined by the doctor.
  • Have measurable disease by CT scan or PET scan.
  • Have received one prior line of chemo-immunotherapy.
  • Have a specific type of large B-cell lymphoma.
  • Have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use two methods of birth control.
  • Men must agree to use contraception and not donate sperm during the study.
  • Willing to provide a tissue sample from a previous biopsy.

Exclusion Criteria

  • Active central nervous system involvement by lymphoma.
  • Lymphoma transformed from chronic lymphocytic leukemia or small lymphocytic lymphoma.
  • Previous organ or stem cell transplant.
  • Recent heart attack or stroke.
  • Significant heart disease or uncontrolled infection.
  • Major surgery within the last four weeks.
  • HIV infection with low CD4 count or high viral load.
  • Active hepatitis B or C infection.
  • Known allergy to study medications.
  • Previous treatment with anti-CD19 therapy or lenalidomide.
  • Gastrointestinal issues affecting medication absorption.
  • History of blood clots and unwilling to take preventive medication.

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