Investigator-Initiated Trial: Sequential Regimen of Intensive Chemotherapy Followed by Stem Cell Transplant for Refractory Lymphoma

Update: this study is closed to enrollment. 

The Weill Cornell Hematologic Malignancies & Bone Marrow Transplant Program is now enrolling men and women with relapsed or refractory lymphoma (non-Hodgkin or Hodgkin) and who are in need of a stem cell transplant for an investigator-initiated clinical trial. The principal investigator is Tsiporah B. Shore, M.D. For more information about the study, please call June Greenberg, RN at (212) 746-2651, e-mail June at, or call the Bone Marrow Transplant Program at (212) 746-2119.

Study Details

This clinical trial is for men and women whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant.

The purpose of the study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage chemotherapy (treatment used for relapsed disease).

Bendamustine is FDA-approved for the treatment of Chronic Lymphocytic Leukemia. Although Bendamustine has been used in stem cell research studies, the timing and combination of Bendamustine and the conditioning regimen BEAM (carmustine, etoposide, cytarabine arabinoside, and melphalan) prior to transplant is not approved by the FDA, thus the combination therapy used in this research study is considered experimental.

Autologous stem cell transplants refer to stem cells that are collected from an individual and given back to that same individual after high dose chemotherapy. With this type of transplant, the person’s stem cells are obtained prior to high-dose chemotherapy, frozen, stored-if necessary, and then given back afterward. Allogeneic stem cell transplantation refers to stem cells that are collected from a donor.

Treatment Plan

Study participants will receive Bendamustine for 2 days in a row to help shrink and kill the lymphoma. Participants who previously had a good partial response to the prior therapy will be assigned to undergo autologous transplantation. Participants who have a partial response with significant relapsed disease will be assigned to undergo an allogeneic stem cell transplant.

After the administration of Bendamustine, participants will have a 1 to 14 day rest period before starting the conditioning regimen. After the rest period, participants will be admitted to the hospital for 4 to 6 weeks, sometimes more. Participants will receive the conditioning regimen (pre-transplant chemotherapy), followed by transplantation.

Participants will be followed for at least one year post-transplant.

Key Eligibility

  • Men and women age 18 and older
  • Relapsed or refractory lymphoma (including Hodgkin lymphoma)
  • Must have received at least one induction therapy and one line of salvage therapy that incorporate at least two standard of care drugs for lymphoma
  • Detailed eligibility reviewed when you contact the study team

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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