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

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

Phase 3

Active, not recruiting

Conditions: Relapsed/Refractory Follicular Lymphoma

Interventions: Biological: Axicabtagene Ciloleucel
Drug: Cyclophosphamide
Drug: Lenalidomide
Drug: Fludarabine
Drug: Rituximab
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Bendamustine

First Posted Date: 2022-05-12

Last Posted Date: 2025-05-09

Lead Sponsor: Kite, A Gilead Company

Target Recruit Count: 230

Registration Number: NCT05371093

Locations: 🇫🇷
Institut Paoli-Calmettes, Marseille, France
🇫🇷
Hopital Saint Eloi, Montpellier, France
🇫🇷
Hopital Pitie-Salpetriere, Paris, France

and more 49 locations

Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy

Phase 1

Active, not recruiting

Conditions: Classical Hodgkin Lymphoma
Hodgkin Disease Refractory
Hodgkin Disease Recurrent

Interventions: Drug: Nivolumab
Drug: Autologous CD30.CAR-T
Drug: Fludarabine
Drug: Bendamustine

First Posted Date: 2022-04-29

Last Posted Date: 2023-04-03

Lead Sponsor: Tessa Therapeutics

Target Recruit Count: 15

Registration Number: NCT05352828

Locations: 🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
University of Miami, Miami, Florida, United States

and more 2 locations

FT576 in Subjects With Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma
Myeloma

Interventions: Drug: FT576 (Allogenic CAR NK cells with BCMA expression)
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Bendamustine
Drug: Daratumumab

First Posted Date: 2022-01-10

Last Posted Date: 2024-08-02

Lead Sponsor: Fate Therapeutics

Target Recruit Count: 31

Registration Number: NCT05182073

Locations: 🇺🇸
Texas Oncology-Medical City Dallas, Dallas, Texas, United States
🇺🇸
Indiana University, Indianapolis, Indiana, United States
🇺🇸
Virginia Oncology Associates, Norfolk, Virginia, United States

and more 11 locations

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Phase 2

Recruiting

Conditions: Diffuse Large B-Cell Lymphoma
DLBCL

Interventions: Biological: Zilovertamab vedotin
Biological: Rituximab
Drug: Gemcitabine
Drug: Bendamustine
Drug: Oxaliplatin
Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

First Posted Date: 2021-12-01

Last Posted Date: 2025-05-16

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 290

Registration Number: NCT05139017

Locations: 🇮🇱
Carmel Hospital ( Site 1103), Haifa, Israel
🇺🇸
Bass Medical Group ( Site 0166), Walnut Creek, California, United States
🇺🇸
Innovative Clinical Research Institute ( Site 0122), Whittier, California, United States

and more 92 locations

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Pirtobrutinib
Drug: Bendamustine
Drug: Rituximab

First Posted Date: 2021-08-27

Last Posted Date: 2025-04-25

Lead Sponsor: Loxo Oncology, Inc.

Target Recruit Count: 250

Registration Number: NCT05023980

Locations: 🇨🇳
Hunan Cancer Hospital, Changsha, Hunan, China
🇧🇷
Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
🇧🇷
Centro Gaucho Integrado - Mae de Deus Center, Porto Alegre, Rio Grande Do Sul, Brazil

and more 105 locations

Observation of the Efficacy of BAd Regimen in the Treatment of Relapsed and Refractory Multiple Myeloma

Phase 3

Conditions: Bendamustine
Multiple Myeloma

Interventions: Drug: Bendamustine

First Posted Date: 2021-08-16

Last Posted Date: 2021-08-16

Lead Sponsor: Liao Aijun

Target Recruit Count: 10

Registration Number: NCT05006469

Locations: 🇨🇳
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China

Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies

Phase 2

Completed

Conditions: Chronic Myeloid Leukemia
Myeloproliferative Neoplasm
Myeloid Leukemia, Acute
Myelodysplastic Syndromes

Interventions: Drug: Bendamustine Hydrochloride
Drug: Cyclophosphamid

First Posted Date: 2021-06-29

Last Posted Date: 2024-10-14

Lead Sponsor: St. Petersburg State Pavlov Medical University

Target Recruit Count: 50

Registration Number: NCT04943757

Locations: 🇷🇺
RM Gorbacheva Research Institute, Saint Petersburg, Russian Federation

Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

Phase 2

Withdrawn

Conditions: Amyloidosis
Light Chain (AL) Amyloidosis

Interventions: Drug: Bendamustine Hydrochloride
Drug: Isatuximab

First Posted Date: 2021-06-29

Last Posted Date: 2024-10-18

Lead Sponsor: Tufts Medical Center

Registration Number: NCT04943302

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Phase 2

Completed

Conditions: Leukemia, Acute Lymphoblastic
Myeloid Leukemia, Acute
Myelodysplastic Syndromes
Myeloproliferative Neoplasm
Lymphoblastic Lymphoma
Biphenotypic Acute Leukemia

Interventions: Drug: Fludarabine
Drug: Bendamustine Hydrochloride
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Mycophenolate Mofetil
Drug: Tacrolimus 5Mg Cap

First Posted Date: 2021-06-28

Last Posted Date: 2024-05-07

Lead Sponsor: St. Petersburg State Pavlov Medical University

Target Recruit Count: 50

Registration Number: NCT04942730

Locations: 🇷🇺
RM Gorbacheva Research Institute, Saint Petersburg, Russian Federation

Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL

Phase 2

Not yet recruiting

Conditions: Lymphoma, Mantle-Cell

Interventions: Drug: Polatuzumab vedotin
Drug: Bendamustine Hydrochloride
Drug: Rituximab

First Posted Date: 2021-06-04

Last Posted Date: 2021-06-04

Lead Sponsor: Czech Lymphoma Study Group

Target Recruit Count: 21

Registration Number: NCT04913103

Locations: 🇨🇿
University Hospital Hradec Králové, Hradec Králové, Czechia
🇨🇿
University Hospital Brno, Brno, Czechia
🇨🇿
University Hospital Kralovske Vinohrady, Prague 10, Czechia

and more 4 locations

Drug Development Updates

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