Phase II Trial Using Low Dose IL-2 to Induce Regulatory T Cells in Patients After Allogeneic Hematopoietic Stem Cell Transplantation as Graft Versus Host Disease Prophylaxis
Participation in this protocol will last about 1 year.
To participate in this study, the patient will need to have undergone a stem cell
transplant. Before the treatment starts, investigators would like to test the patient's
blood blood for the number of regulatory T cells already present before beginning IL-2.
Before the conditioning treatment for the transplant, 30 to 40 ml (6 to 8 teaspoonfuls) of
blood will be collected from the patient for regulatory T cell analysis. Approximately same
amount of blood will also be collected on day 0 (the day of the transplant), and at the
following times after the transplant: day 7 (the day the IL-2 will most likely start) then
weekly for another eleven weeks, then monthly for 8 months.
On approximately day 7 following the transplant, if the patient is well and meets the
eligibility requirements, the IL-2 injections will begin. These will be given subcutaneously
(as a small injection just under the skin) three times per week for 6 weeks. The injections
may also been given through a special catheter, called an Insuflon catheter, that is placed
just under the skin for a week at a time. The first dose must be given in the hospital, but
the remaining doses can be given at home. The patient will be taught how to give the
injections to him/ herself.
If the patient's body has no serious toxicities from the IL-2 and has not developed severe
GVHD, the patient can continue to get the injections the same way for an additional 6 weeks.
If at any time the patient develops severe GVHD or serious toxicity related to the IL-2,the
injections will be stopped. If the patient's disease returns (relapse) or he or she does not
engraft (accept the donor graft), the patient will be removed from the study.
The patient's labs will be followed closely while he/she is receiving the IL-2 injections,
as well as heart, kidney and lung functions; however, these are all standard tests that the
patient will receive after transplant regardless of participation in this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of dose limiting toxicities
Assessment of the safety and the toxicity of low-dose IL-2, administered according to the dosage described in this protocol, in this group of patients
Catherine Bollard, MD
Baylor College of Medicine
United States: Institutional Review Board
H-20971-IL2 for GvHD
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|