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.

Study of CAL-101 in Patients With Indolent B-Cell Non-Hodgkin Lymphoma

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is enrolling patients in a clinical trial testing the experimental drug CAL-101. The study evaluates the efficacy and safety of CAL-101 in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The principal investigator at Weill Cornell is Dr. Peter Martin.

All cells in the body receive signals to grow and survive, but sometimes these signals can get out of control, causing too much cell growth. When cell growth gets out of control, cancers like iNHL can develop. CAL-101 blocks some of the cell functions that cause iNHL to grow and survive. By blocking these functions, CAL-101 may reduce or prevent iNHL from growing and surviving. Results from earlier studies suggest that CAL-101 may help control iNHL.

This is a clinical trial for people with the following types of B-cell indolent non-Hodgkin lymphoma (iNHL):

  • follicular lymphoma
  • small lymphocytic lymphoma
  • lymphoplasmacytoid lymphoma
  • marginal zone lymphoma

Study participants must have received at least 2 different prior treatments for iNHL, and at some point during prior therapy they must have received rituximab and a type of chemotherapy called an alkylating agent.

The purpose of the study is to determine whether the investigational drug CAL-101 is safe and effective for treating people with iNHL once their iNHL has become too difficult to control with available therapies.

CAL-101 is a tablet. Study participants will take CAL-101 twice per day. Participants will be seen for study visits:

  • every 2 weeks for the first 12 weeks of study treatment
  • every 4 weeks until Week 24
  • every 6 weeks until Week 48
  • every 12 weeks until the end of the study

For more information, please call June Greenberg, RN at (212) 746-2651 or email June at

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.

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