Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation
Condition: Leukemia
MeSH terms: Leukemia
Intervention: GM-CSF; Interferon-α-2b
Intervention description: Dosing schedule: 250 mcg/m² subcutaneously Mon-Wed-Fri. Response assessed between 2 and 4 weeks. Duration on study is 3 months.; Dosing schedule: 1.5 mcg/kg subcutaneously Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Leukemia

Summary:

      The relapse of acute leukemia, MDS and blast phase CML after allogeneic transplantation
      affects approximately 1/3 to 1/2 of all transplant recipients and is the main cause of
      treatment failure. There is currently no effective standard treatment for this condition.

      This study will test the activity and feasibility of using a regimen to boost the immune
      system in order to treat AML, ALL, blast phase CML, and MDS relapse after allogeneic
      transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age > 1 year.

          2. Patients who have received an allogeneic transplant to treat AML, ALL, MDS, or CML and
             have relapse or progression of their AML, ALL, MDS, or CML are eligible to participate
             in the study. Relapse is defined as: reappearance of leukemic blasts as determined by
             morphologic analysis of the blood or marrow, reappearance of a phenotypic population
             of leukemia blasts by flow cytometric analysis of the blood or marrow, reappearance of
             a chromosome abnormality which is associated with the original leukemia as determined
             by chromosomal or fluorescence in situ hybridization (FISH) testing (ex: a
             translocation between chromosomes 9 and 22 for CML), reappearance of the molecular
             marker which is associated with the original leukemia as determined by polymerase
             chain reaction (PCR) (ex: breakpoint cluster region [BCR]-Abelson murine leukemia
             [ABL] for CML or ALL).

             *Patients who received allogeneic transplantation to treat AML, ALL, MDS, or CML with
             detectable disease, and did not achieve remission of their leukemia after transplant
             are eligible.

          3. Eastern Cooperative Oncology Group (ECOG) performance status < 2 for adults, and
             Lansky status 60% for children.

          4. Liver functions tests (aspartate transaminase [AST]/alanine aminotransferase
             [ALT]/bilirubin) < 5x the upper limit of normal.

          5. Creatinine < 3x the upper limit of normal.

          6. Lack of active grade 2-4 acute graft-versus-host disease (GVHD) 3 weeks after
             discontinuation of immunosuppression.

          7. Patients with limited stage and extensive stage chronic GVHD of mild severity
             (lichenoid changes), or requiring < prednisone 10 mg/m² daily will be included.

          8. Recipients of grafts procured from related and unrelated donors with any level of
             human leukocyte antigen (HLA)-matching.

        Exclusion Criteria:

          1. Pregnant patients are excluded due to unknown risk to the unborn fetus with cytokines.

          2. Allergy to components of interferon-alpha-2b or GM-CSF.

          3. Current uncontrolled infection.

          4. Current grade 2-4 acute GVHD or chronic extensive GVHD of moderate to severe nature,
             requiring treatment with more than 10 mg/m² of prednisone daily.

          5. Uncompensated heart failure, New York Heart Association (NYHA) class III-IV:

               -  Class I: patients with no limitation of activities; they suffer no symptoms from
                  ordinary activities;

               -  Class II: patients with slight, mild limitation of activity; they are comfortable
                  with rest or with mild exertion;

               -  Class III: patients with marked limitation of activity; they are comfortable only
                  at rest;

               -  Class IV: patients who should be at complete rest, confined to bed or chair; any
                  physical activity brings on discomfort and symptoms occur at rest.

          6. Breast feeding, due to unknown risk to the infant.

          7. Inability to give informed consent.

          8. Children under 1 year of age.