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

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ClinicalTrials.gov Identifier: NCT00539695
Recruitment Status : Completed
First Posted : October 4, 2007
Results First Posted : July 4, 2014
Last Update Posted : May 4, 2018
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):
Rayne Rouce, Baylor College of Medicine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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

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 
Overall Participants Analyzed 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  36.4% 
Male      14  63.6% 
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: Up to 12 weeks on low-dose IL-2 ]

3.  Secondary:   Percentage Change in CD4+ CD25+ FoxP3+ Regulatory T Cells (Tregs) From Pre to Post IL-2 Infusions   [ Time Frame: 12 weeks ]

4.  Other Pre-specified:   Ancillary Studies   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rayne Rouce
Organization: Texas Children's Hospital
phone: 832-824-4716
e-mail: rouce@bcm.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rayne Rouce, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00539695     History of Changes
Other Study ID Numbers: H-20971-IL2 for GvHD
IL-2 for GVHD ( Other Identifier: Baylor College of Medicine )
First Submitted: October 2, 2007
First Posted: October 4, 2007
Results First Submitted: April 22, 2014
Results First Posted: July 4, 2014
Last Update Posted: May 4, 2018