At a glance
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Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, Fludarabine, and 6 other interventions for Hodgkin's Disease. Completed, enrolled 52 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Study Details
Timeline
Interventions
800 mg/m\^2 IV over 30 minutes on Day -7 (1 day)
33 mg/m\^2 IV over 30 minutes Day -5 to Day -2 (4 days)
70 mg/m\^2 IV over 30 minutes on Day -3 to Day -2 (2 days)
2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation. If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant.
Infusion of stem cells on Day 0.
0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.
Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.