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

A Trial to Investigate the Efficacy of Bendamustine in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Refractory to Rituximab.

Phase 3

Terminated

Conditions: Indolent B-cell NHL

Interventions: Drug: Bendamustine IV
Other: Treatment of Physicians Choice

First Posted Date: 2011-02-03

Last Posted Date: 2018-09-04

Lead Sponsor: Mundipharma Research Limited

Target Recruit Count: 88

Registration Number: NCT01289223

Locations: 🇸🇰
Dr Ludmila Demitrovicova, Bratislava, Slovakia
🇦🇺
Royal Adelaide Hospital, Adelaide, Australia
🇦🇺
Princess Alexandra Hospital, Brisbane, Queensland, Australia

Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Ann Arbor Stage III Grade 1 Follicular Lymphoma
Ann Arbor Stage III Grade 3 Follicular Lymphoma
Ann Arbor Stage III Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Ann Arbor Stage IV Grade 1 Follicular Lymphoma
Ann Arbor Stage IV Grade 2 Follicular Lymphoma
Ann Arbor Stage IV Grade 3 Follicular Lymphoma

Interventions: Drug: Bendamustine Hydrochloride
Radiation: Fludeoxyglucose F-18
Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Biological: Ofatumumab
Procedure: Positron Emission Tomography with Radiolabeled Targeting Agent

First Posted Date: 2011-01-31

Last Posted Date: 2025-04-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 135

Registration Number: NCT01286272

Locations: 🇺🇸
Springfield Memorial Hospital, Springfield, Illinois, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
Saint Helena Hospital, Saint Helena, California, United States

and more 93 locations

GIMEMA CLL0809 Study (BendOfa)

Phase 2

Completed

Conditions: Patients With CLL Refractory (SD, PD or CR/PR < 6 Months) Following no More Than Two Prior Treatment Lines
Patients With CLL Relapsing After an Initial Response (CR, PR ≥ 6 Months) Following no More Than Two Prior Treatment Lines; or

Interventions: Drug: Ofatumumab
Drug: Bendamustine

First Posted Date: 2010-11-19

Last Posted Date: 2019-01-25

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 49

Registration Number: NCT01244451

Locations: 🇮🇹
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO, Bolzano, Italy
🇮🇹
Messina Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte", Messina, Italy
🇮🇹
Policlinico di Careggi, Università delgi studi di Firenze, Firenze, Italy

and more 29 locations

Obatoclax Mesylate, Rituximab, and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 1

Withdrawn

Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma

Interventions: Drug: bendamustine hydrochloride
Biological: rituximab
Drug: obatoclax mesylate

First Posted Date: 2010-11-10

Last Posted Date: 2013-06-06

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT01238146

Locations: 🇺🇸
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States

Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Follicular

Interventions: Drug: Bendamustine
Drug: Rituximab
Radiation: Y-90 ibritumomab

First Posted Date: 2010-11-04

Last Posted Date: 2021-05-18

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 39

Registration Number: NCT01234766

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
🇺🇸
Maine Center for Cancer Medicine, Scarborough, Maine, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Phase 2

Completed

Conditions: Diffuse Large B-Cell Lymphoma
Lymphoma, Diffuse Large-Cell
Diffuse Large-Cell Lymphoma
Lymphoma

Interventions: Drug: Bendamustine
Drug: Rituximab

First Posted Date: 2010-11-04

Last Posted Date: 2017-05-24

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 23

Registration Number: NCT01234467

Locations: 🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
Seby B. Jones Cancer Center, Boone, North Carolina, United States
🇺🇸
Northeast Medical Center, Concord, North Carolina, United States

and more 4 locations

Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders

Completed

Conditions: Relapsed or Refractory Chronic Lymphoproliferative Disorders

Interventions: Drug: bendamustine +/- rituximab

First Posted Date: 2010-10-20

Last Posted Date: 2010-10-21

Lead Sponsor: Gruppo Italiano Studio Linfomi

Target Recruit Count: 109

Registration Number: NCT01224769

Locations: 🇮🇹
Gruppo Italiano Studio Linfomi, Modena, Italy

Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

Phase 2

Completed

Conditions: AL Amyloidosis

Interventions: Drug: Bendamustine
Drug: Dexamethasone

First Posted Date: 2010-10-18

Last Posted Date: 2020-03-30

Lead Sponsor: Columbia University

Target Recruit Count: 40

Registration Number: NCT01222260

Locations: 🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States
🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
Columbia University, New York, New York, United States

and more 3 locations