Pentostatin for High Risk and Refractory Chronic Graft Versus Host Disease in Children
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|ClinicalTrials.gov Identifier: NCT00144430|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : February 3, 2009
This is a multicenter trial through the Pediatric Blood and Marrow Transplant Consortium.
The Primary hypothesis of this study is that because of its effect as a potent immunosuppressive agent targeting lymphocytes, pentostatin will show a sustained response in pediatric subjects with severe chronic GVHD. Secondary hypotheses include that the infection and toxicity rate of pentostatin in this setting will be acceptable given its lack of severe myelosuppression, and subjects with refractory chronic GVHD will have significant QOL impairment and symptomatology. These may change as subjects are being treated for their chronic GVHD with pentostatin.
|Condition or disease||Intervention/treatment||Phase|
|Graft vs Host Disease||Drug: Pentostatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pentostatin For the Treatment of High Risk or Refractory Chronic GVHD in Children|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
- Drug: Pentostatin
The drug, Pentostatin, is given every 2 weeks. This drug will be given by intravenous (IV) infusion.
- To estimate the response rate (CR and PR) of pentostatin when used to treat refractory-chronic GVHD in children. [ Time Frame: To end of study ]
- To gather initial efficacy and safety data in high-risk untreated chronic GVHD in children. [ Time Frame: To end of study ]
- To evaluate toxicities of pentostatin when used to treat chronic GVHD in children. [ Time Frame: To end of study ]
- To evaluate quality of life (QOL) and symptoms at diagnosis and after therapy with pentostatin in pediatric patients with refractory chronic GVHD. [ Time Frame: To end of study ]
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): NCT00144430
|Principal Investigator:||David Jacobsohn, MD, MSc||Children's Memorial Hospital, Chicago, IL|