Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
|Hodgkin's Disease||Drug: Gemcitabine Drug: Fludarabine Drug: Melphalan Drug: Antithymocyte Globulin Procedure: Allogeneic Stem Cell Infusion Drug: Tacrolimus Drug: Filgrastim (G-CSF) Drug: Methotrexate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease|
- Number of Participants with Transplant Related Mortality [ Time Frame: Transplant to 100 days post transplant ]Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.
|Study Start Date:||July 2005|
|Study Completion Date:||August 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + Fludarabine + Melphalan
Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes for one day; Fludarabine 33 mg/m^2 IV for 4 days; Melphalan 70 mg/m^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not 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. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
800 mg/m^2 IV over 30 minutes on Day -7 (1 day)
Other Names:Drug: Fludarabine
33 mg/m^2 IV over 30 minutes Day -5 to Day -2 (4 days)
Other Names:Drug: Melphalan
70 mg/m^2 IV over 30 minutes on Day -3 to Day -2 (2 days)Drug: Antithymocyte Globulin
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.
Other Names:Procedure: Allogeneic Stem Cell Infusion
Infusion of stem cells on Day 0.
Other Names:Drug: Tacrolimus
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.
Other Name: PrografDrug: Filgrastim (G-CSF)
Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
Other Name: GranulDrug: Methotrexate
5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.
Other Name: MTX
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385788
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Paolo Anderlini, MD||M.D. Anderson Cancer Center|