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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Cephalon |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00705250 |
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.
Condition | Intervention | Phase |
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Hodgkin's Disease Lymphoma |
Drug: bendamustine hcl |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma. |
Estimated Enrollment: | 37 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
bendamustine hcl 120mg/m2
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Drug: bendamustine hcl
Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion, for two consecutive days. Cycles will be repeated every four weeks and a total of 6 cycles will be planned. Patients will receive pegfilgrastim with each cycle. Treatment will be delayed until the absolute neutrophil count is > 1000/ul and the platelet count is > 75,000/ul.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Craig Moskowitz, MD | moskowic@mskcc.org | |
Contact: Paul Hamlin, MD | hamlinp@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Craig Moskowitz, MD moskowic@mskcc.org | |
Contact: Paul Hamlin, MD hamlinp@mskcc.org | |
Principal Investigator: Craig Moskowitz, MD |
Principal Investigator: | Craig Moskowitz, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Craig Moskowitz, MD ) |
Study ID Numbers: | 08-041 |
Study First Received: | June 24, 2008 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00705250 |
Health Authority: | United States: Institutional Review Board |
Bendamustine HCL |
Lymphatic Diseases Hodgkin's disease Immunoproliferative Disorders Mechlorethamine Hodgkin lymphoma, adult |
Lymphoproliferative Disorders Hodgkin Disease Lymphoma Nitrogen Mustard Compounds Bendamustine |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |