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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

Phase 2
70 Years
Open (Enrolling)
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

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Trial Information

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.

Treatment Plan:

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.

Inclusion Criteria



Patients will be eligible for initial enrollment on this study as long as they meet the
following criteria:

- Diagnosis of acute lymphoblastic leukemia, acute myelogenous leukemia, chronic
myelogenous leukemia, myelodysplastic syndrome, myeloproliferative disorder, Hodgkin
lymphoma, non-Hodgkin lymphoma or non-malignant disease requiring allogeneic HSCT

- Birth to age 70 years of age

- Study entry consent is signed and faxed to Research Coordinator


- At least day +7 post transplant

- Less than or equal to 30 days post transplant

- Lansky or Karnofsky score greater than or equal to 50%

- Total bilirubin less than or equal to 1.5mg/dL

- Alanine aminotransferase level (ALT) less than or equal to five times normal, serum
direct bilirubin less than or equal to 1.5mg/dL, albumin greater than or equal to

- Serum creatinine less than three times normal or creatinine clearance greater than

- Ensure that informed consent signed and faxed to Research Coordinator



Patients will be ineligible to receive IL-2 injections if any of the following is true:

- Active, acute GVHD greater than or equal to grade II

- Serious, active bacterial, fungal or viral infection (i.e. intensive care)

- Clinical Signs of severe pulmonary dysfunction

- Clinical Signs of sever cardiac dysfunction

- Receiving corticosteroids as GVHD treatment

- Hypersensitivity or allergy to IL-2

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of dose limiting toxicities

Outcome Description:

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

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Catherine Bollard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Institutional Review Board

Study ID:

H-20971-IL2 for GvHD



Start Date:

June 2007

Completion Date:

February 2015

Related Keywords:

  • 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
  • Stem Cell transplant
  • Graft verus host disease
  • IL-2
  • 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
  • Graft vs Host Disease
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders



Texas Children's Hospital Houston, Texas  
The Methodist Hospital Houston, Texas  77030