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Last Updated: September 21, 2021

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CLINICAL TRIALS PROFILE FOR TREANDA

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505(b)(2) Clinical Trials for Treanda

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Treanda

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00547534 ↗ Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma Completed Cephalon Phase 2 2007-10-01 The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00547534 ↗ Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma Completed Millennium Pharmaceuticals, Inc. Phase 2 2007-10-01 The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00547534 ↗ Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma Completed University of Rochester Phase 2 2007-10-01 The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00758693 ↗ Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL) Withdrawn Cephalon Phase 2 2008-10-01 Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.
NCT00758693 ↗ Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL) Withdrawn University of Kentucky Phase 2 2008-10-01 Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.
NCT00769522 ↗ FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia Active, not recruiting Mundipharma Pte Ltd. Phase 3 2008-09-01 RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving bendamustine together with rituximab in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared with bendamustine and rituximab in treating patients with previously untreated B-cell chronic lymphocytic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Treanda

Condition Name

Condition Name for Treanda
Intervention Trials
Chronic Lymphocytic Leukemia 18
Multiple Myeloma 10
Non-Hodgkin's Lymphoma 9
Lymphoma 8
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Condition MeSH

Condition MeSH for Treanda
Intervention Trials
Lymphoma 54
Leukemia, Lymphocytic, Chronic, B-Cell 33
Leukemia, Lymphoid 30
Leukemia 28
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Clinical Trial Locations for Treanda

Trials by Country

Trials by Country for Treanda
Location Trials
United States 350
Canada 29
Italy 14
Australia 13
Brazil 6
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Trials by US State

Trials by US State for Treanda
Location Trials
Texas 21
New York 19
California 17
Ohio 15
Washington 14
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Clinical Trial Progress for Treanda

Clinical Trial Phase

Clinical Trial Phase for Treanda
Clinical Trial Phase Trials
Phase 3 10
Phase 2/Phase 3 1
Phase 2 32
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Clinical Trial Status

Clinical Trial Status for Treanda
Clinical Trial Phase Trials
Completed 24
Active, not recruiting 23
Not yet recruiting 16
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Clinical Trial Sponsors for Treanda

Sponsor Name

Sponsor Name for Treanda
Sponsor Trials
National Cancer Institute (NCI) 19
Cephalon 19
M.D. Anderson Cancer Center 12
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Sponsor Type

Sponsor Type for Treanda
Sponsor Trials
Other 81
Industry 65
NIH 19
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