NCT00705250

Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma

A Phase II Study of Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hodgkin's Disease
• Lymphoma

Interventions

Type	Name	Description
DRUG	bendamustine hcl	Patients will receive bendamustine 120mg/m\^2, 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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2008-06-26
• Last updated: 2017-03-03
• Results posted: 2017-01-19

Locations

1 site across 1 country: United States