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

Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma

Phase 1

Active, not recruiting

Conditions: Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Recurrent Mantle Cell Lymphoma
Splenic Marginal Zone Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia

Interventions: Drug: BTK inhibitor PCI-32765
Biological: rituximab
Drug: bendamustine hydrochloride
Other: pharmacogenomic studies
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2011-11-28

Last Posted Date: 2025-02-26

Lead Sponsor: Kami Maddocks, MD

Target Recruit Count: 48

Registration Number: NCT01479842

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

A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Phase 2

Completed

Conditions: Chronic Lymphocytic Leukemia (CLL)

Interventions: Drug: Rituximab
Drug: Bendamustine
Drug: MEDI-551

First Posted Date: 2011-11-06

Last Posted Date: 2017-05-31

Lead Sponsor: MedImmune LLC

Target Recruit Count: 183

Registration Number: NCT01466153

Locations: 🇵🇱
Research Site, Warszawa, Poland

Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide

Phase 1

Completed

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: Bendamustine
Drug: Ofatumumab
Drug: Carboplatin
Drug: Etoposide
Procedure: CT Scan
Procedure: PET Scan
Genetic: Stem Cell Transplant (STC)

First Posted Date: 2011-10-24

Last Posted Date: 2025-04-30

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 38

Registration Number: NCT01458366

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

Phase 3

Completed

Conditions: Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
Drug: Bendamustine plus Rituximab

First Posted Date: 2011-10-20

Last Posted Date: 2024-08-22

Lead Sponsor: University of Giessen

Target Recruit Count: 230

Registration Number: NCT01456351

Locations: 🇩🇪
StiL Head Office; Justus-Liebig-University, Giessen, Germany

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

Phase 1

Completed

Conditions: Refractory/Relapsed Indolent Non-Hodgkin Lymphoma

Interventions: Biological: rituximab
Drug: bendamustine
Drug: lenalidomide

First Posted Date: 2011-09-05

Last Posted Date: 2019-10-08

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 26

Registration Number: NCT01429025

Locations: 🇺🇸
Iowa Lutheran Hospital, Des Moines, Iowa, United States
🇺🇸
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
🇺🇸
Iowa Oncology Research Association CCOP, Des Moines, Iowa, United States

and more 14 locations

A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)

Phase 2

Withdrawn

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: bendamustine
Drug: rituximab
Drug: navitoclax

First Posted Date: 2011-08-26

Last Posted Date: 2016-11-02

Lead Sponsor: Genentech, Inc.

Registration Number: NCT01423539

Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

Phase 2

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: bendamustine
Drug: Fludarabine

First Posted Date: 2011-08-25

Last Posted Date: 2011-08-25

Lead Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH

Target Recruit Count: 96

Registration Number: NCT01423032

Locations: 🇩🇪
Prof. Dr. Norbert Niederle, Leverkusen, NRW, Germany

Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Lymphoma
Mantle Cell Lymphoma

Interventions: Biological: rituximab
Drug: Bendamustine
Drug: bortezomib
Drug: lenalidomide

First Posted Date: 2011-08-12

Last Posted Date: 2025-04-08

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 373

Registration Number: NCT01415752

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Mount Sinai Hospital Medical Center, Chicago, Illinois, United States

and more 413 locations

A Phase 1/2 Study of Lenalidomide in Combination With Bendamustine in Relapsed and Primary Refractory Hodgkin Lymphoma

Phase 1

Conditions: Recurrent Adult Hodgkin Lymphoma

Interventions: Drug: Lenalidomide
Drug: Bendamustine
Other: Bio-specimen Retention

First Posted Date: 2011-08-09

Last Posted Date: 2015-08-11

Lead Sponsor: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Target Recruit Count: 36

Registration Number: NCT01412307

Locations: 🇮🇹
Hematology Oncology and Stem Cell Transplantation Unit , IRCCS Fondazione "G.Pascale", Naples, Italy

S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: bendamustine hydrochloride
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate

First Posted Date: 2011-08-09

Last Posted Date: 2021-10-29

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 53

Registration Number: NCT01412879

Locations: 🇺🇸
Illinois CancerCare - Galesburg, Galesburg, Illinois, United States
🇺🇸
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
🇺🇸
Wenatchee Valley Medical Center, Wenatchee, Washington, United States

and more 200 locations

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