bendamustine hydrochloride

Phase 3Small molecule

bendamustine hydrochloride is one of 138 small molecule programs targeting Mantle Cell Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

137

Competitors

Pipeline

Status by Indication[3][1]

Indication

Mantle Cell LymphomaNot yet recruiting

Non-Hodgkins LymphomaUnknown

Neoplasm of Mature B-CellsUnknown

B-Cell Non-Hodgkins LymphomaUnknown

Childhood LeukemiaUnknown

Classical Hodgkin LymphomaRecruiting

Recurrent Follicular LymphomaRecruiting

Extranodal Marginal Zone B-Cell Lymphoma of Mucosa-Associated Lymphoid TissueActive, not recruiting

Chronic Lymphocytic LeukemiaCompleted

ConditioningRecruiting

Mantle Cell LymphomaPhase 2

Not yet recruiting

Non-Hodgkins LymphomaPreclinical

Unknown

Neoplasm of Mature B-CellsPreclinical

Unknown

B-Cell Non-Hodgkins LymphomaPreclinical

Unknown

Childhood LeukemiaPreclinical

Unknown

Classical Hodgkin LymphomaPhase 2

Recruiting

Recurrent Follicular LymphomaPhase 2

Recruiting

Extranodal Marginal Zone B-Cell Lymphoma of Mucosa-Associated Lymphoid TissuePhase 1

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 3

Completed

ConditioningPhase 2

Recruiting

Competition

Competitive Landscape

94 competitors in Chronic Lymphocytic Leukemia

#DrugCompanyPhaseTrials

Venclexta

AbbVie

Phase 3

51 2

Fludara

Sanofi

Phase 3

38 3

Gazyva

Roche

Phase 3

59 4

Calquence

AstraZeneca

Phase 3

27 5

Revlimid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

40 6

Brukinsa

BBeOne Medicines

Phase 3

17 7

Keytruda

Merck & Co.

Phase 3

2 8

Adcetris

Pfizer

Phase 3

1 9

Beqalzi

BBeOne Medicines

Phase 3

8 10

Campath

GGenzyme, a Sanofi Company

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Classical Hodgkin Lymphoma

NCT04510636

Phase 1Active, not recruiting

Extranodal Marginal Zone B-Cell Lymphoma of Mucosa-Associated Lymphoid Tissue

NCT01479842

Phase 2Active, not recruiting

Liver Lymphoma

NCT04115631

Q1 2027

Phase 2Active, not recruiting

Grade 1 Follicular Lymphoma

NCT03269669

Q2 2027

Phase 3Active, not recruiting

Stage I Chronic Lymphocytic Leukemia

NCT01886872

Q3 2027

Phase 2Not yet recruiting

Mantle Cell Lymphoma

NCT04913103

Clinical

Trials by Indication[1]

Lymphoma9 trials

Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma

Completed·SSwiss Cancer Institute·Phase 1/2·NCT00987493·49 enrolled

CPI-613, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Terminated·WWake Forest University Health Sciences·Phase 1·NCT02168907·1 enrolled

Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Completed·CCephalon·Phase 2·NCT01108341·50 enrolled

Show 6 more trials

A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Completed·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT03343652·30 enrolled

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

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT01238146

A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma

Completed·SSymBio Pharmaceuticals·Phase 1·NCT00389051·9 enrolled

Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Completed·BBeth Christian·Phase 1/2·NCT01535924·26 enrolled

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

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01286272·135 enrolled

A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment

Completed· Teva logo

Teva·Phase 3·NCT01596621·102 enrolled

Chronic Lymphocytic Leukemia8 trials

Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

Unknown status·SShandong Lanjin Pharmaceuticals Co.,Ltd·Phase 3·NCT01657955·96 enrolled

Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 2·NCT01109264·147 enrolled

Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Completed·GGerman CLL Study Group·Phase 2·NCT00274963·60 enrolled

Show 5 more trials

Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01369849·15 enrolled

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia

Active, not recruiting·—·Phase 1·NCT02153580·37 enrolled

Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)

Terminated·—·Phase 1·NCT00947388·9 enrolled

S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

Withdrawn·SSWOG Cancer Research Network·Phase 2·NCT00939328

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01611090·578 enrolled

Multiple Myeloma5 trials

Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02224729·24 enrolled

Carfilzomib, Bendamustine Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02095834·18 enrolled

Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma

Completed·UUniversity of Washington·Phase 2·NCT01110135·43 enrolled

Show 2 more trials

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

Completed·MMayo Clinic·Phase 1/2·NCT01049945·70 enrolled

Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01326702·43 enrolled

Mantle Cell Lymphoma3 trials

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

Not yet recruiting·CCzech Lymphoma Study Group·Phase 2·NCT04913103·21 enrolled

Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

Completed·SSymBio Pharmaceuticals·Phase 2·NCT00612183·56 enrolled

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

Completed·SSWOG Cancer Research Network·Phase 2·NCT01412879·53 enrolled

Diffuse Large B-Cell Lymphoma2 trials

Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma

Completed·UUniversity of Washington·Phase 1/2·NCT01165112·48 enrolled

Bendamustine, Obinutuzumab, and Dexamethasone in Older Patients With Diffuse Large B-cell Lymphoma

Terminated·UUniversity of Chicago·Phase 2·NCT02420210·2 enrolled

18 more indications

Older Patients1 trial

Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT01141725·39 enrolled

Efficacy and Safety1 trial

A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection

Completed· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT04569838·91 enrolled

Conditioning1 trial

BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Recruiting·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT06477549·220 enrolled

Haploidentical Stem Cell Transplantation1 trial

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

Completed·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT04942730·50 enrolled

Lymphoid Malignancies1 trial

CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01664910·27 enrolled

Relapsed or Refractory1 trial

Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer

Completed·UUniversity of California, Davis·Phase 1·NCT02240719·20 enrolled

Small Cell Lung Cancer1 trial

Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 2·NCT00984542·50 enrolled

T-cell non-Hodgkin lymphoma1 trial

CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

Completed·WWake Forest University Health Sciences·Phase 1·NCT02168140·16 enrolled

Glioma1 trial

Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

Completed·UUniversity of Washington·Phase 2·NCT00823797·45 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL

Completed·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT03259529·30 enrolled

Myeloid Malignancies1 trial

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

Completed·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT04943757·50 enrolled

Amyloidosis1 trial

Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

Withdrawn·TTufts Medical Center·Phase 2·NCT04943302

Liver Lymphoma1 trial

A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients </= 70 Years Old With Untreated Mantle Cell Lymphoma

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04115631·360 enrolled

Stage I Chronic Lymphocytic Leukemia1 trial

A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT01886872·547 enrolled

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue1 trial

A Phase I, Dose-escalation Trial of Rituxan and Bendamustine in Combination With Bruton's Tyrosine Kinase Inhibitor, PCI-32765, in Patients With Relapsed Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Indolent Non-Hodgkin's Lymphoma

Active, not recruiting·KKami Maddocks, MD·Phase 1·NCT01479842·48 enrolled

Grade 1 Follicular Lymphoma1 trial

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03269669·73 enrolled

Recurrent Follicular Lymphoma1 trial

A Phase II Study of Brentuximab Vedotin Plus Bendamustine for Relapsed/Refractory Follicular Lymphoma

Recruiting·JJoseph Tuscano·Phase 2·NCT04587687·23 enrolled

Classical Hodgkin Lymphoma1 trial

Phase 2 Study Evaluating the Safety and Efficacy of Pembrolizumab (KEytruda) in Combination With Bendamustine (TREanda) in Relapsed/Refractory Hodgkin Lymphoma

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT04510636·40 enrolled

Sources

References

[1]
ClinicalTrials.gov — 45 trial records for bendamustine hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — bendamustine hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for bendamustine hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — SymBio Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSymBio Pharmaceuticals

bendamustine hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Lymphoma9 trials

Chronic Lymphocytic Leukemia8 trials

Multiple Myeloma5 trials

Mantle Cell Lymphoma3 trials

Diffuse Large B-Cell Lymphoma2 trials

Older Patients1 trial

Efficacy and Safety1 trial

Conditioning1 trial

Haploidentical Stem Cell Transplantation1 trial

Lymphoid Malignancies1 trial

Relapsed or Refractory1 trial

Small Cell Lung Cancer1 trial

T-cell non-Hodgkin lymphoma1 trial

Glioma1 trial

Safety and Efficacy1 trial

Myeloid Malignancies1 trial

Amyloidosis1 trial

Liver Lymphoma1 trial

Stage I Chronic Lymphocytic Leukemia1 trial

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue1 trial

Grade 1 Follicular Lymphoma1 trial

Recurrent Follicular Lymphoma1 trial

Classical Hodgkin Lymphoma1 trial

References

Drug Info

Quick Facts

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