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A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CmML, ALL, MDS, and B Cell Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), B Cell Malignancies

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Trial Information

A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CmML, ALL, MDS, and B Cell Malignancies


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+.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the safety and feasibility of administering WT1 peptides to subjects who have undergone autologous or allogeneic stem cell transplantation for AML, CML, ALL, B cell malignancies and myelodysplastic syndrome.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michael A Morse, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00001360

NCT ID:

NCT00672152

Start Date:

June 2007

Completion Date:

June 2014

Related Keywords:

  • Acute Myelogenous Leukemia (AML)
  • Chronic Myelogenous Leukemia (CML)
  • Acute Lymphoblastic Leukemia (ALL)
  • Myelodysplastic Syndrome (MDS)
  • B Cell Malignancies
  • Autologous transplantation
  • Allogeneic transplantation
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710