Study on Rituximab, Lenalidomide, Acalabrutinib, and Tafasitamab with Chemotherapy for Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04978584

Provider View

This clinical trial is exploring the effects of a combination of drugs, including rituximab, lenalidomide, acalabrutinib, and tafasitamab, with or without chemotherapy, in treating patients with a specific type of newly diagnosed lymphoma. The study aims to see if these treatments can help control the disease.

Patient Parameters

Program Overview

This study is testing a combination of drugs to treat patients with a type of lymphoma called non-germinal center diffuse large B-cell lymphoma. The drugs include rituximab and tafasitamab, which are antibodies that may help stop cancer cells from growing. Acalabrutinib is another drug that may block enzymes needed for cancer cell growth. Chemotherapy drugs like lenalidomide, cyclophosphamide, doxorubicin, and vincristine work in different ways to kill cancer cells or stop them from spreading. Prednisone, an anti-inflammatory drug, is also used to help with treatment. The study is looking at whether using these drugs alone or with chemotherapy can help control this type of lymphoma.

Description

The main goals of this study are to see how well the combination of rituximab, lenalidomide, acalabrutinib, and tafasitamab works in patients with high-risk newly diagnosed non-germinal center diffuse large B-cell lymphoma (DLBCL). Researchers want to find out the response rate after 4 cycles of treatment and the complete response rate after 10 cycles when combined with chemotherapy (CHOP).

Secondary goals include evaluating the overall response rate, survival outcomes, and safety of the treatment. The study will also compare outcomes between patients receiving different cycles of chemotherapy.

The study is divided into two groups:

  • Cohort I (SMART STOP): Patients receive rituximab, acalabrutinib, lenalidomide, and tafasitamab for up to 4 cycles.
  • Cohort II (uLTRA-CHOP): Patients who respond well in Cohort I continue with the same drugs and add chemotherapy for up to 6 cycles. Those with less response receive the same treatment with chemotherapy for up to 6 cycles.

After treatment, patients are monitored every 3 months for a year, then every 4 months for another year.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with diffuse large B-cell lymphoma (DLBCL).
  • No prior treatment except limited radiotherapy, short-term steroids, or a single dose of cyclophosphamide for urgent issues.
  • Age 18 or older and able to give consent.
  • Have measurable disease with a tumor size of at least 1.5 cm.
  • Performance status of 3 or less, if related to lymphoma.
  • Normal liver and kidney function, with specific blood test results.
  • Willing to receive blood transfusions.
  • Registered in the Revlimid REMS program and comply with its requirements.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control.
  • Men must use effective birth control and not donate sperm during and after the study.
  • Able to take aspirin or an alternative for blood clot prevention.

Exclusion Criteria

  • Serious medical conditions like uncontrolled heart disease, diabetes, or infections.
  • Pregnant or breastfeeding women.
  • Allergies to any study drugs.
  • Known HIV, hepatitis B, or C infections unless controlled.
  • Central nervous system involvement with lymphoma.
  • Recent history of other cancers, except certain skin or cervical cancers.
  • Significant nerve damage or neuropathy.
  • Contraindications to required drugs or treatments.
  • Recent blood clots or severe heart issues.
  • Recent major surgery or unhealed wounds.
  • Recent stroke or brain bleeding.
  • Need for certain blood thinners or medications.
  • Recent live vaccinations.
  • Active bleeding disorders.
  • Participation in another clinical trial.

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