Study on ALX148, Rituximab, and Lenalidomide for Treating Slow-Growing and Aggressive B-cell Non-Hodgkin Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05025800

Provider View

This clinical trial is testing a new treatment combination of ALX148, rituximab, and lenalidomide to find the best dose and understand its benefits and side effects for patients with slow-growing and aggressive B-cell non-Hodgkin lymphoma.

Patient Parameters

Program Overview

The study aims to determine the best dose and potential benefits of combining ALX148, rituximab, and lenalidomide for treating patients with both slow-growing and aggressive B-cell non-Hodgkin lymphoma. ALX148 is an immunotherapy that may help the immune system fight cancer, while lenalidomide is a chemotherapy drug that stops cancer cells from growing. Rituximab is a targeted therapy that binds to a protein on B-cells to kill cancer cells. This combination may help control the disease more effectively.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of ALX148 when combined with rituximab and lenalidomide for patients whose B-cell non-Hodgkin lymphoma has returned or not responded to previous treatments. In Phase II, the study will evaluate how well this combination works in patients with untreated, high-burden slow-growing B-cell non-Hodgkin lymphoma.

Participants will receive ALX148 through an IV on specific days, along with rituximab and lenalidomide, which will be given according to a set schedule. The treatment cycles repeat every 28 days unless the disease progresses or side effects become unacceptable. After completing the treatment, patients will have follow-up visits to monitor their health and the treatment's effects for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Phase I: Diagnosed with B-cell non-Hodgkin lymphoma, including various subtypes like marginal zone lymphoma and large B-cell lymphoma.
  • Phase I: Have tried at least one previous treatment and are not eligible for standard curative options.
  • Phase II: Diagnosed with follicular lymphoma or marginal zone lymphoma and have not received prior systemic treatment.
  • Phase II: Have a high tumor burden, meeting specific criteria like large tumor size or certain symptoms.
  • Phase II: Stage III or IV disease with measurable tumors.
  • Aged 18 years or older.
  • Good overall health with a performance status of 0 or 1.
  • Adequate blood cell counts and organ function based on specific tests.
  • Women of childbearing potential and men must use effective birth control during and after the study.
  • Women must have a negative pregnancy test before starting the study.
  • Willing to sign informed consent and comply with study requirements.

Exclusion Criteria

  • Active central nervous system lymphoma or certain other types of lymphoma.
  • History of other cancers unless disease-free for 3 years.
  • Serious medical conditions that could affect safety or study outcomes.
  • Active infections like HIV, hepatitis B, or hepatitis C.
  • History of severe allergic reactions to study drugs.
  • Significant heart disease or recent heart attack.
  • Recent stroke or bleeding disorders.
  • Pregnant or breastfeeding women.
  • Recent major surgery or investigational drug use.
  • Life expectancy less than 6 months.
  • Prior treatment with lenalidomide or similar drugs.
  • Difficulty swallowing or absorbing oral medication.
  • Active autoimmune diseases requiring treatment in the past 2 years.

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