Clinical trial NCT00433745 (phase 2, status: completed)
Conditions: myelodysplastic syndrome, acute myeloid leukemia (aml), chronic myeloid leukemia (cml)
ICD codes: D46.9, D46.C, D46.Z, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: wt1 peptide vaccine
SMILES: [O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O
Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Diagnosed with

                  refractory anemia with excess of blasts (MDS-RAEB).

                  or

                  refractory anemia with excess of blasts in transformation (MDS-RAEBt).

                  or

                  secondary acute myelogenous leukemia (AML).

                  or

                  relapsed or refractory acute or chronic myelogenous leukemias (AML).

                  or

                  relapsed or refractory chronic myelogenous leukemias (CML) with accelerated phase
                  or blast crisis

                  or

                  relapsed or refractory acute lymphoblastic leukemia (high risk ALL).

                  or

                  acute lymphoblastic leukemia (ALL) in complete remission.

                  or

                  chronic myelomonocytic leukemia (CMML).

               2. Unsuitable for stem cell transplantation (age over sixty or unavailability of a
                  fully-matched donor).

                  or

                  made an informed decision not to undergo the transplant procedure.

                  or

                  relapsed AML, CML, MDS or ALL post stem cell transplantation (SCT).

               3. HLA-A0201 positive.

               4. Ages 18 - 85 years.

               5. Off all lympho-ablative chemotherapeutic agents.

               6. All subjects (men and women) must agree to practice abstinence or effective
                  contraception during the study period.

        Inclusion Criteria Donor (for post transplant subjects without available donor lymphocyte
        infusion (DLI) cells):

          1. Related donor, HLA identical (6/6) with recipient.

          2. Age greater than or equal to 18 or less than or equal to 80 years old.

          3. Ability to comprehend the investigational nature of the study and provide informed
             consent.

        EXCLUSION CRITERIA:

          1. HIV positive (HIV-infected patients are immune-compromised and it is unlikely that
             these patients will be capable of mounting an immune response to the vaccine).

          2. Treatment with systemic corticosteroids within 7 days prior to study entry.

          3. Low bone marrow reserves (less than 20 percent cellularity).

          4. Serum creatinine greater than 2.5mg/dl or serum bilirubin greater than 4mg/dl
             (patients receiving fludarabine).

          5. Co-morbidity of such severity that it would preclude the patient's ability to tolerate
             protocol therapy.

          6. Predicted survival less than 3 months.

          7. Previous allergic reaction to Montanide Adjuvant.

          8. Pregnant or breast feeding (Pregnant and breast-feeding women are excluded from study
             because the effects of vaccination are not known and may pose a risk to the developing
             fetus. All female patients will have a urine pregnancy test, and only those that test
             negative will be allowed on study).

          9. Enrolled in another vaccine clinical trial during the study period.

         10. Inability to comprehend the investigational nature of the study and provide informed
             consent.

        Exclusion Criteria-Donor (any of the following):

          1. Pregnant or lactating.

          2. Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts,
             history of stroke, uncontrolled hypertension).

          3. HIV positive.

          4. Severe psychiatric illness. Mental deficiency sufficiently severe as to make
             compliance with the bone marrow transplant (BMT) treatment unlikely and making
             informed consent impossible.