NEWS HIGHLIGHTS
Published Studies Related to Treanda (Bendamustine)
Efficacy of bendamustine in rituximab-refractory indolent B-cell non-Hodgkin lymphoma: review of a pivotal trial. [2011.01]
B-cell malignancies, including B-cell non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL), are the most common hematologic malignancies in the western world. Although excellent response rates are achieved with standard chemoimmunotherapy, patients often relapse and additional treatment is necessary...
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.
Phase II STUdy with 3rd- or 4th-line bendamustine (flat dose) therapy in patients with metastatic breast cancer. [2009.09]
BACKGROUND: Bendamustine is a drug with a favorable side effect spectrum and it offers a chance to overcome tumor resistance in pretreated patients with metastatic breast cancer (MBC)... CONCLUSIONS: Bendamustine can be given with a fixed flat dose, which simplifies the drug preparation. 2/5th of all treated patients responded to this therapy whereas bendamustine showed no anticancer effect in 3/5th of all patients. Bendamustine is definitely a drug with anticancer potential.
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.
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.
Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma [Recruiting]
The goal of this Phase II study is to add bortezomib to the highly active regimen of
bendamustine and rituximab. In this study, bortezomib will be administered on a weekly
schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles.
This combination uses the standard bendamustine dosing schedule, and is more convenient
than the 5-week regimen of these 3 drugs currently being studied. This trial will be
conducted at multiple study sites by the Sarah Cannon Research Institute (SCRI) Oncology
Research Consortium.
Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma [Recruiting]
The standard treatment for patients with HL that has not responded to treatment or has come
back after treatment is stem cell transplant. When patients are not eligible for transplant
or when HL comes back after transplant, there are no standard treatment options. These
patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a
chemotherapy agent that is effective in treating patients with various diseases, including
non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for
the treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern
Europe have shown that bendamustine HCl is likely effective for treating HL. This study will
find out the effect of bendamustine HCl for transplant-ineligible patients with HL that has
not responded to or has come back after treatment.
PH2 Trial in Patietns With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab [Not yet recruiting]
Investigational Drugs:
Ofatumumab (Azerra) + bendamustine (Trenda)
Route of Administration:
Intravenous (IV)
Hypothesis:
This study is designed to assess the toxicity and overall response rate. Ofatumumab is a
fully human monoclonal antibody (A type of protein made in the laboratory that can bind to
substances in the body, including tumor cells) that shows promising activity in the
treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an
FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is
given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.
Participation:
Approximately 37 relapsed/refractory CLL subjects will participate in this study over two
years.
Treatment Plan:
A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV
300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by
bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be
administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1
only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg
will be given on day 1 only.
Follow-up:
Patients will be followed monthly for six months, then every three months for five years
then annually thereafter.
Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma [Recruiting]
The goal of this clinical research study is to learn if the combination of bendamustine
hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.
The safety of this drug combination will also be studied.
Reports of Suspected Treanda (Bendamustine) Side Effects
Pyrexia (67),
Rash (63),
White Blood Cell Count Decreased (38),
Platelet Count Decreased (33),
Neutrophil Count Decreased (32),
Pancytopenia (30),
Neutropenia (30),
Pneumonia (29),
Nausea (29),
Fatigue (28), more >>
|
