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.

ASCO Update:Bendamustine plus rituximab beats CHOP plus rituximab as first-line treatment for indolent and mantle cell lymphoma

By Peter Martin, MD

At the plenary session of the American Society of Clinical Oncology (ASCO) on Sunday, June 3, Dr. Mattias Rummel from Germany presented updated results from a phase 3 trial initially presented at the American Society of Hematology (ASH) in 2009. The study compared bendamustine plus rituximab (BR) to CHOP chemotherapy plus rituximab (R-CHOP) in over 500 patients with indolent and mantle cell lymphoma.

Now with a median follow-up period of 45 months, the updated data were consistent with the previously reported findings. Bendamustine plus rituximab (BR) was better tolerated than R-CHOP, with significantly less neutropenia, fewer infections, and no alopecia (hair loss), and was also more effective, reducing the risk of progression roughly two-fold.

Importantly, there was no difference in the rate of transformation to aggressive lymphoma, the rate of secondary malignancies, and the ability to collect stem cells. These data support the design of ongoing and planned cooperative group trials further evaluating the first-line use of BR and BR-based combinations.

In his discussion of the abstract, Dr. Michael Williams from the University of Virginia agreed that the data were promising but cautioned that a peer-reviewed publication of the data remains to be seen.

Lymphoma in the News: Family History May Be a Risk Factor for Non-Hodgkin Lymphoma

By Peter Martin, MD

A recently published study from investigators at Stanford University and in Lund University in Sweden used data from a large Swedish cohort study, birth records, and cancer registries to look for risk factors associated with development of non-Hodgkin lymphoma (NHL). The investigators evaluated the records of over 3.5 million people, including 936 with NHL, born between 1973 and 2008.

They reported that family history of NHL was associated with development of NHL in early life. Specifically, history of NHL in a sibling increased the risk of developing NHL roughly nine-fold while having a parent with NHL increased the risk of NHL roughly two-fold. Importantly, the overall incidence rate of NHL was 1.4 per 100,000 person-years (the number of people x the number of years of follow-up per person). Therefore, a two-fold increase, although statistically significant, would only have increased the rate to roughly 3 per 100,000 person years. Moreover, only 4 of the 936 cases had a sibling with NHL and 10 had a parent with NHL.

These small numbers, although statistically significant, make it difficult to make any definitive conclusions regarding the degree of risk. The lack of data regarding environmental exposures, infections, and other co-existing conditions (e.g., immunodeficiencies) make it difficult to determine whether the familial association of NHL is due to an inherited condition or some other unmeasured factor. Despite the issues, the results are consistent with the concept that genetic factors may contribute to NHL. It is possible that contemporary studies using next generation sequencing of the genomes of patients and family members could yield more conclusive results. The risks and benefits of such studies, however, need to be weighed very carefully.