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.

PD0332991 Shows Promising Signs of Activity in Mantle Cell Lymphoma in Phase 1 Trial at Weill Cornell

By Peter Martin, MD

Cancer cells in mantle cell lymphoma (MCL) undergo uncontrolled proliferation due to overproduction of the protein Cyclin D1. The family of proteins called Cyclins combine with enzymes called Cyclin dependent kinases (Cdk) in a way that is analgous to gas in an engine. The Cdks are the engine but they rely on the Cyclins to make them work.

PD0332991 is an orally bioavailable (i.e., a pill) inhibitor of Cdk4/6, the Cdks that combine with Cyclin D1 in MCL. A recently published clinical trial  performed at Weill Cornell Medical College and other sites around the United States demonstrated that PD0332991 could successfully stop MCL tumors from growing in several patients, including one response that lasted for more than 30 months. Biopsies taken from patients while receiving PD0332991 revealed that Cdk4/6 was effectively inhibited while a specialized kind of imaging, called FLT-PET, demonstrated that MCL cells had stopped proliferating. Although these results were promising, not every patient benefited, and the responses were not permanent.

Additional studies combining PD0332991 with other drugs based on promising laboratory data are currently underway at Weill Cornell. Click here for more information.

Dr. John Leonard Discusses Antibody Therapy in Lymphoma

Weill Cornell’s Dr. John Leonard discusses antibody therapy in lymphoma in a Medscape CME program. Click here to view the presentation.