Low Dose IL-2, Hematopoietic Stem Cell Transplantation, IL2 for GVHD

This study has been completed.
Sponsor:
Collaborators:
The Methodist Hospital System
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Kathryn Leung, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00539695
First received: October 2, 2007
Last updated: June 3, 2014
Last verified: June 2014
Results First Received: April 22, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Lymphoblastic Leukemia
ALL
Acute Myelogenous Leukemia
AML
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorder
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Non-malignant Diseases Requiring Allogeneic HSCT
Intervention: Biological: IL-2

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IL2 Administration

SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.

Time will be measured as 'week beginning with first IL-2 injection.'

T cell Induction via IL-2 to reduce GVHD

IL-2: IL2 Administration:

Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection.


Participant Flow:   Overall Study
    IL2 Administration  
STARTED     25  
Evaluable Patients     22 [1]
COMPLETED     12  
NOT COMPLETED     13  
[1] Patients who received IL-2.



  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
IL2 Administration

SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.

Time will be measured as 'week beginning with first IL-2 injection.'

T cell Induction via IL-2 to reduce GVHD

IL-2: IL2 Administration:

Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection.


Baseline Measures
    IL2 Administration  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Median ( Inter-Quartile Range )
 
less than 20 yrs     13  
  ( 9 to 15 )  
greater and equal 20 yrs     47.5  
  ( 30.5 to 59.5 )  
Gender  
[units: participants]
 
Female     8  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures

1.  Primary:   Rate of Dose Limiting Toxicities   [ Time Frame: 6-12 weeks ]

2.  Secondary:   Rate of Severe (Grade III or IV) Acute GVHD   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Immunomodulatory Effects of IL-2 Administered After Allogeneic Hematopoietic Stem Cell Transplantation Will be Evaluated by Descriptive Statistics.   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   Ancillary Studies   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Dr. Kathryn Leung
Organization: Texas Children's Hospital
phone: 832-824-4219
e-mail: kleung@bcm.edu


No publications provided


Responsible Party: Kathryn Leung, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00539695     History of Changes
Other Study ID Numbers: H-20971-IL2 for GvHD, IL-2 for GVHD
Study First Received: October 2, 2007
Results First Received: April 22, 2014
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration