CLINICAL TRIALS PROFILE FOR BENDAMUSTINE HYDROCHLORIDE
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505(b)(2) Clinical Trials for BENDAMUSTINE HYDROCHLORIDE
| 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 | >Sponsor | >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 | >Sponsor | >Phase | >Start Date | >Summary |
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