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

Associated Therapies: -

Clinical Trials

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

Pharmacokinetics of Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy

Phase 1

Completed

Conditions: Malignancy

Interventions: Drug: bendamustine

First Posted Date: 2009-03-18

Last Posted Date: 2012-04-23

Lead Sponsor: Cephalon

Target Recruit Count: 6

Registration Number: NCT00863850

Locations: 🇳🇱
Please Call For Information, Amsterdam, Netherlands

Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors

Phase 1

Completed

Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: bendamustine
Other: laboratory biomarker analysis
Procedure: Surgical Resection of Brain Metastases
Radiation: Stereotactic body radiation therapy

First Posted Date: 2009-02-06

Last Posted Date: 2018-05-17

Lead Sponsor: John Grecula

Target Recruit Count: 18

Registration Number: NCT00837928

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: bendamustine
Drug: erlotinib
Drug: Maintenance erlotinib

First Posted Date: 2009-02-03

Last Posted Date: 2018-04-17

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 11

Registration Number: NCT00834678

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 2

Completed

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: bendamustine
Drug: rituximab

First Posted Date: 2009-01-29

Last Posted Date: 2016-04-19

Lead Sponsor: Pharmatech

Target Recruit Count: 61

Registration Number: NCT00831597

Locations: 🇺🇸
Pharmatech Oncology Study Site, Richardson, Texas, United States

A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

Phase 1

Completed

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: Cyclophosphamide
Drug: Bendamustine
Drug: Doxorubicin
Drug: Fludarabine
Drug: Obinutuzumab
Drug: Prednisone
Drug: Vincristine

First Posted Date: 2009-01-19

Last Posted Date: 2016-11-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 137

Registration Number: NCT00825149

Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

Phase 2

Completed

Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Neoplasm

Interventions: Drug: Bendamustine Hydrochloride
Other: Quality-of-Life Assessment

First Posted Date: 2009-01-16

Last Posted Date: 2017-07-07

Lead Sponsor: University of Washington

Target Recruit Count: 45

Registration Number: NCT00823797

Locations: 🇺🇸
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States