Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00388349|
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Disease Hodgkin's Lymphoma Lymphoma||Drug: Gemcitabine Drug: Vinorelbine Drug: Carmustine Drug: Etoposide Drug: Cyclophosphamide Procedure: Autologous HCT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||September 2010|
Experimental: Gemcitabine + Autologous HCT
Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide.
Other Name: Gemzar
Other Name: Navelbine
Other Name: BCNU
Other Name: Vepesid
Procedure: Autologous HCT
Other Name: Peripheral blood stem cell (PBSC) rescue
- Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity [ Time Frame: 6 months ]Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.
- Pulmonary Toxicity (BCNU Pneumonitis) [ Time Frame: 2 years ]Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).
- Overall Survival (OS) [ Time Frame: 2 years ]Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).
- Relapse Post-transplant [ Time Frame: 2 years ]Reports the percentage of participants that experienced relapse post-transplant.
- Survival Measures [ Time Frame: 2 years ]
Reports the survival measures:
- Freedom from progression (FFP)
- Event-free survival (EFS)
- Overall survival (OS)
EFS and OS were estimated by Kaplan-Meier method
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
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): NCT00388349
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sally Arai, MD||Stanford University|