Low Dose IL-2, Hematopoietic Stem Cell Transplantation, IL2 for GVHD
Condition: 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
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Myeloproliferative Disorders
Intervention: IL-2
Intervention description: 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.
Intervention MeSH terms: Aldesleukin; Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: No
Keywords: 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

Summary:

      Patients are being asked to participate in this study because treatment for their disease
      requires a stem cell transplant (SCT). Stem cells are the source of normal blood cells found
      in the bone marrow and lead to recovery of blood counts after bone marrow transplantation.
      With stem cell transplants, regardless of whether the donor is a full match to the patient or
      not, there is a risk of developing graft-versus-host disease (GVHD).

      GVHD is a serious and sometimes fatal side effect of SCT. GVHD occurs when the new donor stem
      cells (graft) recognizes that the body tissues of the patient (host) are different from those
      of the donor. When this happens, cells in the graft may attack the host organs. How much this
      happens and how severe the GVHD is depends on many things, including how different the donors
      cells are, the strength of the drugs given in preparation for the transplant, the quality of
      transplanted cells and the age of the person receiving the transplant.

      Typically, acute GVHD occurs in the first 100 days following transplant, while chronic GVHD
      occurs after day 100. Acute GVHD most often involves the skin, where it can cause anywhere
      from a mild rash to complete removal of skin; liver, where it can anywhere from a rise in
      liver function tests to liver failure; and the gut, where it can cause anywhere from mild
      diarrhea to profuse, life-threatening diarrhea. Most patients who develop GVHD experience a
      mild to moderate form, but some patients develop the severe, life-threatening form.

      Previous studies have shown that patients who receive SCT's can have a lower number of
      special T cells in their blood, called regulatory T cells, than people who have not received
      stem cell transplants. When regulatory T cells are low, there appears to be an increased rate
      of severe, acute GVHD. A drug known as IL-2 (Proleukin) has been shown to increase the number
      of regulatory T cells in patients following stem cell transplant, and in this study
      investigators plan to give low dose IL-2 after transplant.

      This study is called a phase II study because its major purpose is to find out whether using
      a low-dose of IL-2 will be effective in preventing acute GVHD. Other important purposes are
      to find out if this treatment helps the patient's immune system recover regulatory T cells
      faster after the transplant. This study will assess the safety and toxicity of low-dose IL-2
      given to patients after transplantation and determine whether this drug is helpful in
      preventing GVHD.
    

Eligibility criteria:

        INCLUSION CRITERIA:

        INCLUSION CRITERIA FOR INITIAL STUDY ENROLLMENT:

        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

        INCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION:

          -  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
             3.0gm/dL

          -  Serum creatinine less than three times normal or creatinine clearance greater than
             80mg/min/1.73m2

          -  Ensure that informed consent signed and faxed to Research Coordinator

        EXCLUSION CRITERIA:

        EXCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION:

        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