We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074035
First Posted: December 11, 2003
Last Update Posted: April 14, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: January 26, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Graft Versus Host Disease
Intervention: Drug: pentostatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between December 2003 and March 2008, 39 participants were recruited to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 participant cancelled prior to receiving treatment and is excluded from all analyses.

Reporting Groups
  Description
Pentostatin pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks

Participant Flow:   Overall Study
    Pentostatin
STARTED   38 
COMPLETED   38 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
1 participant cancelled prior to receiving treatment and is excluded from all analyses.

Reporting Groups
  Description
Pentostatin pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks

Baseline Measures
   Pentostatin 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Years]
Median (Full Range)
 48 
 (28 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  34.2% 
Male      25  65.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   5.3% 
Not Hispanic or Latino      29  76.3% 
Unknown or Not Reported      7  18.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   2.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   7.9% 
White      30  78.9% 
More than one race      1   2.6% 
Unknown or Not Reported      3   7.9% 
Region of Enrollment 
[Units: Count of participants]
 
United States   38 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: 3 months ]

2.  Secondary:   Grade 3 or Higher Non-hematologic Adverse Events   [ Time Frame: Duration of treatment (up to 5 years) ]

3.  Secondary:   Overall Survival At 1 Year   [ Time Frame: 1 year ]

4.  Secondary:   Overall Survival At 2 Years   [ Time Frame: 2 year ]

5.  Secondary:   Pharmacokinetics   [ Time Frame: At initiation of Tx and at 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sherif S. Farag, M.D., Ph.D.
Organization: The Ohio State University Medical Center
e-mail: farag-1@medctr.osu.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00074035     History of Changes
Other Study ID Numbers: CALGB-100101
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000341678 ( Registry Identifier: NCI Physician Data Query )
First Submitted: December 10, 2003
First Posted: December 11, 2003
Results First Submitted: January 26, 2017
Results First Posted: March 15, 2017
Last Update Posted: April 14, 2017