High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.
Procedure: Stem Cell Transplantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic Cell Support for Patients With Relapsed/Refractory Hodgkin's Disease|
- Event-Free Survival (EFS) [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]Time to event (TTE) will be monitored. Event defined as relapse, tumor progression or death. EFS and overall survival (OS) time estimated using Kaplan-Meier estimator. For EFS analysis, participants who experience tumor relapse, disease progression, or death considered to be an event.
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + Busulfan + Melphalan
Gemcitabine 2775 mg/m2 by vein over about 3 hours on days -8 and -3. Busulfan 32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient. AUC 4,000 by vein over about 3 hours on days -8 to -5. Melphalan 60 mg/m2 by vein over about 30 minutes on days -3 and -2. Palifermin 60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2. Infusion of stem cells on Day 0.
2775 mg/m2 by vein over about 3 hours on days -8 and -3.
Other Names:Drug: Busulfan
32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient
AUC 4,000 by vein over about 3 hours on days -8 to -5.
Other Names:Drug: Melphalan
60 mg/m2 by vein over about 30 minutes on days -3 and -2.
Other Name: AlkeranProcedure: Stem Cell Transplantation
Infusion of stem cells on Day 0.
Other Name: SCTDrug: Palifermin
60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.
Other Name: Kepivance
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01200329
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Yago Nieto, MD, PHD||M.D. Anderson Cancer Center|