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Last Updated: June 26, 2022

CLINICAL TRIALS PROFILE FOR BENDAMUSTINE HYDROCHLORIDE


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505(b)(2) Clinical Trials for Bendamustine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00974233 ↗ Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL Completed Celgene Corporation Phase 2 2009-10-01 The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination NCT00974233 ↗ Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL Completed University of Wisconsin, Madison Phase 2 2009-10-01 The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Formulation NCT02162888 ↗ A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients Completed Eagle Pharmaceuticals, Inc. Phase 1 2013-11-01 The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Bendamustine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00069758 ↗ Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma Completed Cephalon Phase 2 2003-09-01 Summary: As this is an open label study, all patients will receive SDX-105 by 30-60 minute intravenous infusion on day 1 and day 2. Treatment will repeat every 21 days. Treatment can continue for up to one year in the absence of disease progression or unacceptable toxicity. Patients will be followed until disease progression. Rationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in patients who are refractory to Rituxan.
NCT00076349 ↗ SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL) Completed Cephalon Phase 2 2004-04-01 SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
NCT00139841 ↗ Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab Completed Cephalon Phase 3 2005-10-01 SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
NCT00274963 ↗ Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Completed German CLL Study Group Phase 2 2004-10-01 RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bendamustine together with mitoxantrone works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.
NCT00274989 ↗ Bendamustine and Rituximab in Treating Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia Completed University of Cologne Phase 2 2005-11-01 CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic benefits of using bendamustine in combination with rituximab for the treatment of patients with previously untreated or relapsed CLL.
NCT00274989 ↗ Bendamustine and Rituximab in Treating Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia Completed German CLL Study Group Phase 2 2005-11-01 CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic benefits of using bendamustine in combination with rituximab for the treatment of patients with previously untreated or relapsed CLL.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bendamustine Hydrochloride

Condition Name

Condition Name for Bendamustine Hydrochloride
Intervention Trials
Chronic Lymphocytic Leukemia 50
Mantle Cell Lymphoma 31
Multiple Myeloma 31
Lymphoma 27
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Condition MeSH

Condition MeSH for Bendamustine Hydrochloride
Intervention Trials
Lymphoma 207
Leukemia, Lymphocytic, Chronic, B-Cell 87
Lymphoma, Non-Hodgkin 84
Leukemia, Lymphoid 84
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Clinical Trial Locations for Bendamustine Hydrochloride

Trials by Country

Trials by Country for Bendamustine Hydrochloride
Location Trials
Italy 269
Spain 127
Canada 125
Australia 96
Japan 77
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Trials by US State

Trials by US State for Bendamustine Hydrochloride
Location Trials
Texas 77
California 73
New York 69
Illinois 49
Florida 47
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Clinical Trial Progress for Bendamustine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Bendamustine Hydrochloride
Clinical Trial Phase Trials
Phase 4 3
Phase 3 51
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Bendamustine Hydrochloride
Clinical Trial Phase Trials
Completed 151
Recruiting 57
Active, not recruiting 50
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Clinical Trial Sponsors for Bendamustine Hydrochloride

Sponsor Name

Sponsor Name for Bendamustine Hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 33
Cephalon 33
Hoffmann-La Roche 21
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Sponsor Type

Sponsor Type for Bendamustine Hydrochloride
Sponsor Trials
Other 308
Industry 284
NIH 33
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