CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
bendamustine hcldrug
Likely dose
bendamustine hcl 120mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00705250
NCT00705250Phase 2Completed

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

Memorial Sloan Kettering Cancer Center·interventional·Posted Jun 26, 2008·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating bendamustine hcl for Hodgkin's Disease and Lymphoma. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCephalon

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 26, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 18.0 years ago

Interventions

bendamustine hcldrug

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.