Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host 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: NCT00074035|
Recruitment Status : Completed
First Posted : December 11, 2003
Results First Posted : March 15, 2017
Last Update Posted : May 8, 2018
RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.
PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: pentostatin||Phase 2|
- Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin.
- Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the infection rate in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the changes in lymphocyte populations in patients treated with this drug.
- Determine the survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.
Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease|
|Actual Study Start Date :||December 2003|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||November 1, 2014|
treatment of pts with refractory graft vs host disease
4 mg/sq m IV infusion over 20-30 min q 2 weeks
- Response Rate [ Time Frame: 3 months ]
Percentage of participants who had a complete or partial response defined by the Hopkins scoring system.
A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.
- Grade 3 or Higher Non-hematologic Adverse Events [ Time Frame: Duration of treatment (up to 5 years) ]Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.
- Overall Survival At 1 Year [ Time Frame: 1 year ]Percentage of patients who were alive at 1 year.
- Overall Survival At 2 Years [ Time Frame: 2 year ]Percentage of patients who were alive at 2 years.
- Pharmacokinetics [ Time Frame: At initiation of Tx and at 3 months ]
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): NCT00074035
|United States, Delaware|
|Tunnell Cancer Center at Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, Illinois|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612-7243|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Union Hospital Cancer Program at Union Hospital|
|Elkton, Maryland, United States, 21921|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital|
|Pittsburgh, Pennsylvania, United States, 15224-1791|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||Sherif S. Farag, MD, PhD||Ohio State University|