At a glance
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A Pilot Study of a Sequential Regimen of Intensive Chemotherapy Followed by Autologous or Allogeneic Transplantation for Refractory Lymphoma (Non-Hodgkin's and Hodgkin's) and Phase 2 Expansion Cohort
In Brief
A Phase 2 clinical trial evaluating Bendamustine, Carmustine, and 7 other interventions for Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma. Completed, enrolled 34 participants across 1 site.
Detailed Summary
This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant. The purpose of this study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage (treatment used for relapsed disease) chemotherapy.
Study Details
Timeline
Interventions
Days - 24 and Day - 23 followed by a short break of 10 - 14 days.
300 mg/m2 on Day -6
100 mg/m2 on days -5 to -2
140mg/m2 on Day -1
200 mg/m2 on days -5 to -2
20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors
Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant