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Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

This study has been completed.
Sponsor:
Collaborator:
Astex Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00506922
First received: July 20, 2007
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: March 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Interventions: Drug: Pentostatin
Drug: Tacrolimus
Drug: Methotrexate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: September 15, 2000 to July 26, 2007; All recruitment done at UT MD Anderson Cancer Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 150 patients were enrolled, and 147 were available for analysis. Two patients assigned to the 1.5 mg/m2 arm were removed without receiving treatment (due to ineligibility, and poor donor cell collection). A patient assigned to arm 2.0 mg/m2 withdrew consent before being treated.

Reporting Groups
  Description
No Pentostatin Group 1: No Pentostatin
Pentostatin 0.5 Group 2: Pentostatin 0.5 mg/m^2
Pentostatin 1 Group 3: Pentostatin 1 mg/m^2
Pentostatin 1.5 Group 4: Pentostatin 1.5 mg/m^2
Pentostatin 2 Group 5: Pentostatin 2 mg/m^2

Participant Flow:   Overall Study
    No Pentostatin     Pentostatin 0.5     Pentostatin 1     Pentostatin 1.5     Pentostatin 2  
STARTED     37     10     29     63     11  
COMPLETED     37     10     29     61     10  
NOT COMPLETED     0     0     0     2     1  
Physician Decision                 0                 0                 0                 2                 0  
Withdrawal by Subject                 0                 0                 0                 0                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
No Pentostatin Group 1: No Pentostatin
Pentostatin 0.5 Group 2: Pentostatin 0.5 mg/m^2
Pentostatin 1 Group 3: Pentostatin 1 mg/m^2
Pentostatin 1.5 Group 4: Pentostatin 1.5 mg/m^2
Pentostatin 2 Group 5: Pentostatin 2 mg/m^2
Total Total of all reporting groups

Baseline Measures
    No Pentostatin     Pentostatin 0.5     Pentostatin 1     Pentostatin 1.5     Pentostatin 2     Total  
Number of Participants  
[units: participants]
  37     10     29     63     11     150  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     36     10     28     61     11     146  
>=65 years     1     0     1     2     0     4  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 19     42  ± 23     47  ± 20     50  ± 22     45  ± 32     46.8  ± 23.2  
Gender  
[units: participants]
           
Female     15     3     11     30     7     66  
Male     22     7     18     33     4     84  
Region of Enrollment  
[units: participants]
           
United States     37     10     29     63     11     150  



  Outcome Measures

1.  Primary:   Number of Patients Without GVHD at 100 Days   [ Time Frame: 100 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marcos de Lima, MD / Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-3219
e-mail: bmcmullin@mdanderson.org


No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00506922     History of Changes
Other Study ID Numbers: ID00-132
Study First Received: July 20, 2007
Results First Received: March 1, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board