Product Description
Bendamustine injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Bendamustine injection is also used to treat a type of non-Hodgkins lymphoma (NHL: cancer that begins in a type of white blood cell that normally fights infection) that is slow spreading, but has continued to worsen during or after treatment with another medication. Bendamustine is in a class of medications called alkylating agents. It works by killing existing cancer cells and limiting the growth of new cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a608034.html)
Mechanisms of Action: CD20 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, New Zealand, Poland, Portugal, Romania, Serbia, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States
Active Clinical Trial Count: 29
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Chronic Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma|Lymphoma
Phase 2: Acute Respiratory Distress Syndrome|Follicular Lymphoma|Hodgkin Lymphoma|Lung Cancer|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Mesothelioma|Pleural Cancer|Waldenstrom Macroglobulinemia
Phase 1: Psoriasis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2018-003270-27 |
CLL2-BZAG | P2 |
Active, not recruiting |
Chronic Lymphoid Leukemia |
2026-02-28 |
2022-03-13 |
Treatments |
|
NCT02401503 |
CLL2-BAG | P2 |
Completed |
Acute Respiratory Distress Syndrome|Chronic Lymphoid Leukemia |
2024-12-10 |
2025-06-11 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT06854003 |
BRAZAN | P2 |
Recruiting |
Mantle-Cell Lymphoma |
2029-11-01 |
12% |
2025-10-30 |
|
NCT06557330 |
HM-225 | P2 |
Not yet recruiting |
Lymphoma, Non-Hodgkin |
2027-09-29 |
2025-01-07 |
||
NCT03755804 |
cHOD17 | P2 |
Active, not recruiting |
Hodgkin Lymphoma |
2027-01-01 |
12% |
2025-09-23 |
|
NCT06561347 |
ZEBRA | P2 |
Recruiting |
Waldenstrom Macroglobulinemia |
2026-12-01 |
12% |
2026-06-10 |
Patient Enrollment|Primary Endpoints|Treatments |
2023-509354-58-00 |
ACE-LY-308 | P3 |
Active, not recruiting |
Lymphoma |
2027-05-15 |
32% |
2025-05-02 |
Treatments |
NCT05551936 |
BTCRC LYM20-463 | P2 |
Active, not recruiting |
Follicular Lymphoma |
2026-05-01 |
12% |
2026-02-18 |
Primary Endpoints|Treatments|Trial Status |
NCT02763319 |
B-MIND | P3 |
Completed |
Diffuse Large B-Cell Lymphoma |
2024-06-21 |
2025-07-18 |
Patient Enrollment|Primary Endpoints|Start Date |
|
ACTRN12621000011886p |
2006-7041-83/hah | P1 |
Not yet recruiting |
Psoriasis |
2021-07-07 |
|||
NCT03872180 |
IRB00102827 | P2 |
Active, not recruiting |
Mantle-Cell Lymphoma |
2022-06-06 |
2025-08-07 |
Primary Completion Date|Primary Endpoints|Treatments |
|
ACTRN12620001264976p |
2006-7041-83/hah | P2 |
Not yet recruiting |
Lung Cancer|Mesothelioma|Pleural Cancer |
None |
|||
CTR20131462 |
CTR20131462 | P2 |
Recruiting |
Lymphoma |
None |
2025-04-29 |
Treatments |
|
CTR20131457 |
CTR20131457 | P2 |
Recruiting |
Chronic Lymphoid Leukemia |
None |
2025-04-29 |
Treatments |
|
2025-524241-27-00 |
ICP-CL-00128 | P3 |
Not yet recruiting |
Lymphoma |
2031-03-05 |
|||
2014-004689-11 |
B-MIND | P3 |
Completed |
Diffuse Large B-Cell Lymphoma |
2024-06-21 |
2025-07-09 |
Treatments |
|
jRCT2080224718 |
jRCT2080224718 | P1 |
Recruiting |
Diffuse Large B-Cell Lymphoma |
2025-03-31 |
|||
CTR20130089 |
CTR20130089 | P1 |
Active, not recruiting |
Lymphoma, Non-Hodgkin |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
NCT05848765 |
REFRACT | P2 |
Recruiting |
Follicular Lymphoma |
2029-05-31 |
12% |
2024-11-27 |
|
NCT05300282 |
FIL_A-BEGEV | P2 |
Recruiting |
Hodgkin Lymphoma |
2027-04-27 |
12% |
2024-07-31 |
|
NCT04624906 |
BRAWM | P2 |
Active, not recruiting |
Waldenstrom Macroglobulinemia |
2025-12-31 |
12% |
2026-02-05 |
Primary Completion Date|Primary Endpoints|Treatments |
2011-000097-56 |
HOVON 110 FL / GLSG / NCRI | P2 |
Completed |
Follicular Lymphoma |
2024-12-31 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2019-004898-63 |
FIL_Copa-RB | P2 |
Completed |
Diffuse Large B-Cell Lymphoma |
2024-12-19 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2014-000580-40 |
CLL2-BAG | P2 |
Completed |
Chronic Lymphoid Leukemia |
2024-12-17 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2016-002347-41 |
CheckMate 744 | P2 |
Completed |
Hodgkin Lymphoma |
2024-05-28 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments |