A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation (WT-1)

This is an interventional treatment trial for Acute Myelogenous Leukemia (AML) focused on measuring Autologous transplantation, Allogeneic transplantation Read More

Inclusion Criteria:

There are two subgroups of patients: Those undergoing autologous stem cell transplantation and those undergoing allogeneic stem cell transplantation.

Autologous transplant subgroup:

-Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who will be undergoing autologous stem cell transplantation.

Allogeneic transplantation subgroup:

-Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who have undergone allogeneic stem cell transplantation. There is no limitation on whether myeloablative or non-myeloablative chemotherapy is administered. A 3/6 or greater match is required for patients who have had an allogeneic stem cell transplant.

Both subgroups:

• Subject must be one of the following HLA types: HLA A2, A24, DR15 or DRw53 (includes HLA-DR4, -DR7, and DRw9)
• Karnofsky performance status must be greater than or equal to 70%.
• Age ≥ 18 years.
• Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
• Patient must agree to use adequate contraception defined as: for women, one of the following (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); for men, one of the following: (1) surgical sterilization, or (2) a condom used with a spermicide.
• In order to receive their immunizations, subjects should be:

For autologous transplants:

• At least 2 weeks from prior chemotherapy.
• Injections 1 and 2 must be completed prior to administration of any growth factor mobilization
• Injections 3, 4, 5, and 6, to resume 2 or more weeks from the time of their stem cell infusion if there has been no Grade 3 or 4 non-hematologic, major organ toxicity within the preceding 1 week. Non-major organ toxicities must have resolved to grade 2 or less.

For allogeneic transplants,

• At least 2 weeks from the time of their stem cell infusion.
• Without Grade 3 or 4 non-hematologic major organ toxicity within the preceding 1 week; non major organ toxicities must have resolved to grade 2 or less.

• We will require demonstration of >50% donor myeloid hematopoiesis, based on microsatellite polymorphisms, prior to enrolling the patients with MDS on the study.

  • Adequate laboratory data as follows:

Hematologic function: WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets ≥ 50,000/microliter ((may transfuse).

Renal and hepatic function: serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except a bilirubin of <2.0 will be permitted for patents with Gilbert's syndrome), SGOT/SGPT < 2 x upper limit of normal.

• Subjects must have a CD4+ count is > 200/mm. There is no specified requirement for CD8+ T cell count.
• Urine protein/creatinine ratio (UPC) must be less than 1.

Exclusion Criteria:

• Corticosteroid (greater than 10mg per day of prednisone or an equipotent dose of another corticosteroid) or other immunosuppressive therapy within the prior 1 week.
• Pregnant women and nursing mothers.
• Current or prior history of brain metastases.
• More than 12 months since their stem cell transplant.
• HIV +, hepatitis BsAg +, Hepatitis C Ab+.