Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
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|ClinicalTrials.gov Identifier: NCT00385788|
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : August 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease|
|Study Start Date :||July 2005|
|Primary Completion Date :||August 2016|
|Study Completion Date :||August 2016|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|