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

Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Bendamustine
Drug: Fludarabine
Drug: Rituximab

First Posted Date: 2010-03-31

Last Posted Date: 2019-09-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 51

Registration Number: NCT01096992

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

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Bendamustine

First Posted Date: 2010-03-18

Last Posted Date: 2016-05-23

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

Target Recruit Count: 43

Registration Number: NCT01088984

Locations: 🇺🇸
Teva Investigational Site 15, New York, New York, United States
🇺🇸
Teva Investigational Site 17, Orange, California, United States
🇺🇸
Teva Investigational Site 12, San Diego, California, United States

and more 47 locations

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Phase 1

Completed

Conditions: Chronic Lymphocytic Leukemia
Indolent Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Idelalisib
Drug: Bortezomib
Drug: Rituximab
Drug: Ofatumumab
Drug: Fludarabine
Drug: Everolimus
Drug: Chlorambucil
Drug: Bendamustine
Drug: Lenalidomide

First Posted Date: 2010-03-17

Last Posted Date: 2021-03-18

Lead Sponsor: Gilead Sciences

Target Recruit Count: 241

Registration Number: NCT01088048

Locations: 🇺🇸
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
🇺🇸
Willamette Valley Cancer Institute and Research Center, Springfield, Oregon, United States
🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States

and more 8 locations

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Phase 3

Terminated

Conditions: Lymphoma, Follicular

Interventions: Drug: Ofatumumab
Drug: Ofatumumab and Bendamustine infusions (Arm A)
Drug: Bendamustine infusion
Drug: Bendamustine infusion (Arm B)

First Posted Date: 2010-03-01

Last Posted Date: 2020-03-27

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 346

Registration Number: NCT01077518

Locations: 🇬🇧
Novartis Investigative Site, Uxbridge, United Kingdom

Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

Phase 3

Completed

Conditions: Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Bendamustine
Drug: Rituximab

First Posted Date: 2010-02-23

Last Posted Date: 2014-04-24

Lead Sponsor: Cephalon

Target Recruit Count: 54

Registration Number: NCT01073163

Locations: 🇺🇸
Geisinger Medical Center, Danville, Pennsylvania, United States
🇺🇸
The Hospital of Central Connecticut, New Britain, Connecticut, United States
🇺🇸
Hematology Oncology Physicans Extenders Group, Tucson, Arizona, United States

and more 40 locations

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia

Phase 2

Active, not recruiting

Conditions: Hairy Cell Leukemia

Interventions: Drug: Rituximab
Drug: Pentostatin
Drug: Bendamustine
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Epinephrine
Drug: Antihistamines
Drug: Corticosteroids
Drug: Bronchodilators
Other: Intravenous (IV) Saline

First Posted Date: 2010-02-01

Last Posted Date: 2025-04-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 69

Registration Number: NCT01059786

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

Phase 3

Completed

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: Bendamustine
Drug: Obinutuzumab

First Posted Date: 2010-02-01

Last Posted Date: 2020-01-13

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 413

Registration Number: NCT01059630

Locations: 🇺🇸
South Texas Inst of Cancer, Corpus Christi, Texas, United States
🇺🇸
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 116 locations

Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bendamustine
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2010-01-26

Last Posted Date: 2017-05-03

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 59

Registration Number: NCT01056276

Locations: 🇺🇸
Hematology Oncology Clinic, LLP, Baton Rouge, Louisiana, United States
🇺🇸
Los Robles Hospital and Medical Center, Thousand Oaks, California, United States
🇺🇸
Florida Cancer Specialists, Ft. Myers, Florida, United States

and more 10 locations

A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)

Phase 4

Completed

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: bendamustine
Drug: chlorambucil
Drug: rituximab [MabThera/Rituxan]

First Posted Date: 2010-01-26

Last Posted Date: 2015-06-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 357

Registration Number: NCT01056510

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Phase 1

Completed

Conditions: Refractory Multiple Myeloma

Interventions: Drug: bendamustine hydrochloride
Drug: lenalidomide
Drug: dexamethasone

First Posted Date: 2010-01-15

Last Posted Date: 2020-02-11

Lead Sponsor: Mayo Clinic

Target Recruit Count: 70

Registration Number: NCT01049945

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

and more 2 locations

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