Study on R-ICE and Lenalidomide for Treating Relapsed or Resistant Diffuse Large B-Cell Lymphoma

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02628405

Provider View

This clinical trial is testing a combination of chemotherapy drugs and lenalidomide to see if it can effectively treat patients with diffuse large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding lenalidomide to a chemotherapy regimen called R-ICE can help treat diffuse large B-cell lymphoma (DLBCL) that has either come back after treatment or not responded to previous therapies. The study will also determine the best dose of lenalidomide to use with R-ICE and evaluate the safety and effectiveness of this combination.

Description

This study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of lenalidomide when combined with the chemotherapy drugs rituximab, ifosfamide, carboplatin, and etoposide (R-ICE). In Phase II, the study will assess how well this combination works in treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Participants will receive lenalidomide orally for 14 days, along with rituximab, ifosfamide, carboplatin, and etoposide given intravenously over several days. This treatment cycle will repeat every 21 days for up to 2 cycles, with the possibility of additional cycles based on the patient's response and doctor's discretion.

The study will also look at how many patients can proceed to stem cell transplant after treatment, the overall survival rates, and any side effects experienced. Researchers will also explore how the treatment affects different subtypes of DLBCL and the reduction of cancer markers in the body.

After completing the study treatment, patients will be monitored regularly for up to five years to track their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • For Phase I: Must have a confirmed diagnosis of B-cell lymphoma expressing the CD20 marker.
  • For Phase II: Must have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) expressing the CD20 marker.
  • Must have at least one measurable tumor.
  • Must have received only one previous line of treatment for lymphoma.
  • Must be in good overall health with an ECOG performance status of 0 to 2.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Must be willing to provide informed consent and comply with study requirements.
  • Must be considered eligible for a stem cell transplant by the study doctor.
  • Must be willing to participate in the REVLIMID REMS program and take aspirin daily as a precaution against blood clots.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Individuals not willing to use effective contraception.
  • Individuals with severe health conditions that could interfere with the study.
  • Individuals with active infections or compromised immune systems.
  • Individuals with a recent history of heart attack or severe heart conditions.
  • Individuals with other active cancers within the past three years, except for certain skin or cervical cancers.
  • Individuals unable to take blood clot prevention medications.
  • Individuals with a history of extensive radiation therapy.
  • Individuals with active or prior central nervous system lymphoma.
  • Individuals with active hepatitis B infection.

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