Bendamustine

Generic Name: Bendamustine

Brand Names: Belrapzo, Bendeka, Treanda, Vivimusta

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₂₁Cl_₂N_₃O_₂

CAS Number: 16506-27-7

Unique Ingredient Identifier: 9266D9P3PQ

Background: Bendamustine is a nitrogen mustard drug indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.

Indication: Bendamustine is indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Associated Conditions: Chronic Lymphocytic Leukemia, Follicular Non-Hodgkin's Lymphoma Refractory, Refractory Hodgkin Lymphoma, Refractory Mantle Cell Lymphoma, Waldenström's Macroglobulinemia (WM), Recurrent multiple myeloma, Refractory indolent B cell non-hodgkin lymphoma

Clinical Trials

S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

Phase 2

Withdrawn

Conditions: Leukemia

First Posted Date: 2009-07-15

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Registration Number: NCT00939328

Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: bendamustine
Drug: bortezomib

First Posted Date: 2009-06-15

Last Posted Date: 2012-10-04

Lead Sponsor: Cephalon

Target Recruit Count: 40

Registration Number: NCT00920855

Locations: 🇺🇸
Family Cancer Center, PLLC, Collierville, Tennessee, United States
🇺🇸
Pacific Oncololgy & Hematology, Encinitas, California, United States
🇺🇸
James R. Berenson, M.D., Inc., West Hollywood, California, United States

and more 10 locations

Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Melphalan
Drug: Bendamustine

First Posted Date: 2009-06-09

Last Posted Date: 2019-06-04

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 57

Registration Number: NCT00916058

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma

Phase 2

Terminated

Conditions: Follicular Lymphoma

Interventions: Drug: Bendamustine
Drug: Mitoxantrone
Drug: Rituximab

First Posted Date: 2009-05-14

Last Posted Date: 2020-04-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 14

Registration Number: NCT00901927

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)

Phase 2

Terminated

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Lenalidomide
Drug: Fludarabine
Drug: Rituximab
Procedure: Stem Cell Transplantation
Drug: Thymoglobulin
Drug: Bendamustine
Drug: Allopurinol

First Posted Date: 2009-05-12

Last Posted Date: 2020-01-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 39

Registration Number: NCT00899431

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Bendamustine
Drug: Rituximab

First Posted Date: 2009-05-01

Last Posted Date: 2014-11-04

Lead Sponsor: Cephalon

Target Recruit Count: 45

Registration Number: NCT00891839

Locations: 🇺🇸
Teva Investigational Site 11, Fountain Valley, California, United States
🇺🇸
Teva Investigational Site 41, Grapevine, Texas, United States
🇺🇸
Teva Investigational Site 35, Orlando, Florida, United States

and more 10 locations

Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant

Phase 1

Completed

Conditions: Follicular Lymphoma
Mantle Cell Lymphoma
CD20 Positive
Chronic Lymphocytic Leukemia
Marginal Zone Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
T-Cell Non-Hodgkin Lymphoma

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Bendamustine
Biological: Filgrastim
Drug: Fludarabine
Drug: Methotrexate
Biological: Rituximab
Drug: Tacrolimus

First Posted Date: 2009-04-14

Last Posted Date: 2019-06-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 60

Registration Number: NCT00880815

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors

Phase 1

Terminated

Conditions: Brain Metastases

Interventions: Drug: Bendamustine

First Posted Date: 2009-04-09

Last Posted Date: 2012-12-18

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 12

Registration Number: NCT00879073

Locations: 🇺🇸
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study

Phase 3

Completed

Conditions: Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: bendamustine
Drug: rituximab
Drug: vincristine
Drug: prednisone
Drug: cyclophosphamide
Drug: doxorubicin

First Posted Date: 2009-04-07

Last Posted Date: 2018-02-05

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Target Recruit Count: 447

Registration Number: NCT00877006

Locations: 🇺🇸
Teva Investigational Site 52, Fountain Valley, California, United States
🇺🇸
Teva Investigational Site 72, Augusta, Georgia, United States
🇺🇸
Teva Investigational Site 48, Chicago, Illinois, United States

and more 125 locations

Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Bendamustine HCL

First Posted Date: 2009-03-23

Last Posted Date: 2018-07-24

Lead Sponsor: University of Arizona

Target Recruit Count: 10

Registration Number: NCT00867503

Locations: 🇺🇸
Arizona Cancer Center, Tucson, Arizona, United States

Drug Development Updates

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