Tag: lenalidomide

New Weill Cornell Study: Thalidomide and Lenalidomide + Rituximab (ThRiL) for Previously Treated Waldenstrom Macroglobulinemia

A Phase 2 Trial of Daily Alternating Thalidomide and Lenalidomide Plus Rituximab (ThRiL) for Patients with Previously Treated Waldenstrom Macroglobulinemia

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now enrolling patients in a newly opened, investigator-initiated clinical trial for people with previously treated Waldenstrom Macroglobulinemia. The principal investigator is Peter Martin, MD.

For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at amr2017@med.cornell.edu.

Key eligibility

  • Previously treated for Waldenstrom Macroglobulinemia
  • Not currently treated with other anti-cancer agents or treatments
  • No prior treatment with thalidomide or lenalidomide
  • Detailed eligibility reviewed when you contact the study team

Study Details

The study is evaluating the efficacy and safety of daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in people with previously treated Waldenstrom Macroglobulunemia (WM).

Thalidomide and lenalidomide are drugs that modulate the immune system and have been shown to bring about responses in patients with WM. However, their use has been limited due to side effects. Alternating doses of thalidomide and lenalidomide may alleviate the side effects while preserving the effectiveness of the therapies.

Treatment Plan

  • Thalidomide every ODD day of a 28 day cycle
  • Lenalidomide every EVEN day of a 28 day cycle
  • Rituximab on Days 1, 8, 15 and 22 and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycles 7, 13, 19, etc)

Study participants may continue to receive thalidomide and lenalidomide until their disease worsens.

New Clinical Trial: Lenalidomide + Rituximab as Front-Line Therapy for Untreated Mantle Cell Lymphoma

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now enrolling patients in a new, investigator-initiated phase II study of lenalidomide in combination with rituximab in patients with previously untreated Mantle Cell Lymphoma (MCL). The study is led by Jia Ruan, MD. This study may be a good option for patients with MCL who need to travel to New York City to participate in a trial because lenalidomide, the study medication, can be taken at home. After the first month on study, patients will be seen in clinic on average of once a month.

Significant progress has been made in the treatment of mantle cell lymphoma; however, the majority of patients with Mantle Cell Lymphoma are not cured of their disease with current available chemotherapy-based options. The initial treatment for MCL is not standardized, and intensive chemotherapy does not seem to provide substantial benefit compared to conservative management in terms of long-term survival and quality-of-life measurements.

Researchers have recently discovered that the tumor microenvironment—the normal cells and blood vessels that surround a tumor–can contribute to tumor growth by providing blood supply and creating an environment that allows the tumor to grow. Biological compounds that disrupt the interaction and dependence of tumor cells with their microenvironment have shown promise in lymphoma therapy, including mantle cell lymphoma.

The purpose of this study is to test the synergy of combining lenalidomide, a biological agent that targets the tumor microenvironment, and rituximab, an antibody that targets lymphoma cells. By including a maintenance phase of lenalidomide and rituximab therapy, we hope to improve treatment effectiveness and maintain quality of life for patients. Continue reading “New Clinical Trial: Lenalidomide + Rituximab as Front-Line Therapy for Untreated Mantle Cell Lymphoma”

Lymphoma in the News: Lenalidomide Plus Rituximab Shows Promise as First-Line Therapy in Patients with Indolent Non-Hodgkin Lymphoma

By Peter Martin, MD

The results of a phase 2 study of lenalidomide plus rituximab in patients with previously untreated indolent lymphoma were presented at the American Society of Clinical Oncology annual meeting in June 2011. Investigators at MD Anderson Cancer Center treated 75 patients (41 with follicular lymphoma, 19 with marginal zone lymphoma, 15 with chronic lymphocytic leukemia) with the combination and found that 90% of patients responded, with 66% achieving a complete response. Treatment was generally well tolerated, with only 5 patients stopping due to toxicity.

These results are exciting due both to the promising response rate and the fact that cytotoxic chemotherapy was not a part of the treatment regimen: Lenalidomide is an immunomodulatory agent and rituximab is a biologic agent/monoclonal antibody.

Currently, the CALGB is conducting a similar phase 2 trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. The trial is being led by Dr. Rebecca Elstrom at Weill Cornell Medical Center and will provide important confirmatory evidence in a larger group of patients treated at multiple centers around the country. (Update: this study is closed to enrollment.)

Dr. Jia Ruan at Weill Cornell is leading a study of lenalidomide plus rituximab as front-line therapy for patients with previously untreated mantle cell lymphoma (click here for more information on this trial).

A phase 3 trial comparing lenalidomide plus rituximab to chemotherapy plus rituximab in patients with previously untreated follicular lymphoma is being considered in Europe.