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Treanda (Bendamustine Hydrochloride) - Summary

 



TREANDA SUMMARY

TREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient.

TREANDA® (bendamustine hydrochloride) for Injection is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.


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NEWS HIGHLIGHTS

Media Articles Related to Treanda (Bendamustine)

Pivotal Data Published In The Journal Cancer Demonstrate That TREANDA Induced Durable Responses In Relapsed Indolent Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.06]
Cephalon, Inc. (Nasdaq: CEPH) announced the journal Cancer has published a pivotal study demonstrating that TREANDA® (bendamustine HCl) for Injection induced durable responses in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had progressed during or within six months of treatment with rituximab.

New Data On Bendamustine Offers Hope To Non-Hodgkin's Lymphoma Patients Resistant To Standard Therapy
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.06]
New data published today in the journal, Cancer, reveals that three quarters (75%) of patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), responded to treatment with Bendamustine following a single-arm, multicentre study. Significantly, all patients participating in the study had become resistant or were unresponsive to rituximab (the standard treatment for the disease) when used either as a single agent or in combination with other therapies. Professor Brad S.

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Published Studies Related to Treanda (Bendamustine)

Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. [2009.09.10]
PURPOSE: This randomized, open-label, parallel-group, multicenter study was designed to compare the efficacy and safety of bendamustine and chlorambucil in previously untreated patients with advanced (Binet stage B or C) chronic lymphocytic leukemia (CLL)... CONCLUSION: Bendamustine offers significantly greater efficacy than chlorambucil, and a manageable toxicity profile, when used as first-line therapy in patients with advanced CLL.

Treatment of Bendamustine and Prednisone in patients with newly diagnosed multiple myeloma results in superior complete response rate, prolonged time to treatment failure and improved quality of life compared to treatment with Melphalan and Prednisone-a randomized phase III study of the East German Study Group of Hematology and Oncology (OSHO). [2006.04]
Purpose: This randomized phase III study compared bendamustine and prednisone (BP) to standard melphalan and prednisone (MP) treatment in previously untreated patients with multiple Myeloma (MM). Patients and Methods: To be included, patients had to have histologically and cytologically proven stage II with progressive diseases or stage III MM...

Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19). [2006.02]
PURPOSE: The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine + prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine + prednisone (COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma... CONCLUSIONS: Bendamustine can efficaciously and safely replace cyclophosphamide, as used in standard COP therapy, for the treatment of patients with indolent NHL and mantle cell lymphoma. Long-term survival data suggest a clinically significant benefit for patients treated with BOP.

Bendamustine prolongs progression-free survival in metastatic breast cancer (MBC): a phase III prospective, randomized, multicenter trial of bendamustine hydrochloride, methotrexate and 5-fluorouracil (BMF) versus cyclophosphamide, methotrexate and 5-fluorouracil (CMF) as first-line treatment of MBC. [2005.09]
Two i.v. regimens, bendamustine, methotrexate and 5-fluorouracil (BMF) and cyclophosphamide, methotrexate and 5-fluorouracil (CMF) were compared as first-line therapy in a randomized, open, multicenter phase III trial including 364 patients with metastatic breast cancer (MBC)... Thus, bendamustine, when replacing cyclophosphamide in the CMF combination, can be expected to produce longer progression-free survival in first-line treatment of MBC.

Bendamustine in the treatment of multiple myeloma: results and future perspectives. [2002.08]
Multiple myeloma (MM) is a malignancy of terminally differentiated plasma cells typically occurring in elderly patients.This article describes a prospective, randomized, phase III study designed to compare the efficacy of bendamustine/prednisolone with a standard melphalan/prednisolone regimen.

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Clinical Trials Related to Treanda (Bendamustine)

Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma [Recruiting]
The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDAâ„¢), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.

Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma [Recruiting]
Primary Objectives:

- To evaluate the complete response rate of the combination of bendamustine,

mitoxantrone, and rituximab in previously untreated follicular non-Hodgkin's lymphoma.

Secondary Study Objectives:

- To evaluate the toxicity and safety of BMR in patients with untreated follicular

lymphoma.

- To determine the time to progression (TTP) in patients with untreated follicular

lymphoma following treatment with BMR.

- To evaluate the overall response rate of the combination of bendamustine, mitoxantrone,

and rituximab in previously untreated follicular non-Hodgkin's lymphoma.

Exploratory objectives

- To determine the correlation between molecular complete response and response to

therapy.

- To examine the immediate and prolonged effects of BMR on immune effector cell number

and function.

Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors [Recruiting]
The purpose of this study is to:

- Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation

therapy

- To determine the plasma pharmacokinetics (a blood test to see how much of the drug is

getting into the patient's system and how long it lasts in the system) of Bendamustine and

- To determine the presence of Bendamustine in cerebrospinal fluid (CSF) (fluid from the

brain and spinal cord) of study patients.

Bendamustine is approved by the FDA for chronic lymphocytic leukemia. However, Bendamustine will be used in this study as an investigational agent.

Fludarabine, Bendamustine and Rituximab Conditioning for Patients With Lymphoid Malignancies [Recruiting]
The goal of this clinical research study is to learn if bendamustine, when given with a stem cell transplant and chemotherapy (fludarabine and rituximab), can help the transplanted stem cells start to grow and make new blood cells in patients with leukemia and lymphoma. The safety of this combination will also be studied.

Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL) [Recruiting]
Patients will be treated with bendamustine at a fixed, standard dose. Escalating doses of alemtuzumab will be administered. A cycle is defined as a 4 week period with alemtuzumab administered on Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26.

Patients will be enrolled and treated within 28 days after screening. Alemtuzumab and bendamustine will be administered to cohorts of at least 3 patients. Dose escalation will occur by sequential cohort. Escalation of subsequent cohorts will occur no sooner than 28 days after the last patient in the cohort receives the first cycle Day 1 of treatment. Dose escalation will only occur in the absence of protocol specified dose limiting criteria at the current dose.

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Page last updated: 2009-11-06

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