A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation (WT-1)
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ClinicalTrials.gov Identifier: NCT00672152 |
Recruitment Status
:
Terminated
(low accrual)
First Posted
: May 6, 2008
Last Update Posted
: December 10, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myelogenous Leukemia (AML) Chronic Myelogenous Leukemia (CML) Acute Lymphoblastic Leukemia (ALL) Myelodysplastic Syndrome (MDS) B Cell Malignancies | Biological: WT1 derived peptides | Phase 1 |
Two subgroups with 2 dose cohorts of up to 6 patients each will be enrolled in this exploratory study in order to attempt to obtain immunologic and clinical data on patients with a variety of hematologic malignancies and amongst those in remission and early relapse. The 2 subgroups of patients will be treated with different schemas depending upon whether they are undergoing or have undergone autologous or allogeneic stem cell transplantation.
For the autologous transplant patients: Immune monitoring will require 90ml peripheral blood before the first immunization, 3-5 ml from the leukapheresis product, 40-90ml peripheral blood before the 4th immunization immunizations, after the last immunization (week 6-8), and at the discretion of the immune monitoring lab, every two months if immunizations are continued.
For the allogeneic transplant patients: Immune monitoring will require 90ml peripheral blood before the first immunization, 40-90ml peripheral blood before the 4th immunization immunizations, after the last immunization (week 6-8), and at the discretion of the immune monitoring lab, every two months if immunizations are continued.
Subjects will be monitored with blood pressure, temperature, and pulse, pre-injection, at 15 and 30 minutes after injection, prior to being allowed to leave the clinic. Diphenhydramine 50 mg, solumedrol 100 mg, and epinephrine 1:1000 (1 mL) must be available bedside (or a clinic code cart must be available). If hypotension (SBP <90mmHg for patients with baseline SBP > 110mmHg or > 20 mmHg decrease for those with baseline SBP< 110 mmHg), urticaria or orofacial or laryngeal edema or bronchospasm occurs, an IV line will be placed and the diphenhydramine 50 mg, solumedrol 100 mg, and epinephrine 1:1000 sq are recommended. In this event, patients will be transported emergently to the emergency room if stabilized or the code team will be contacted if patients continue to have progression of symptoms or worsening hypotension. For fever>101.5, acetaminophen 650 mg may be given orally.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: A-WT1 derived peptides
Wilms' tumor gene 1 (WT1) derived peptides consisting of 0.3mg (cohort 1) or 1mg (cohort 2) of each of the following peptides mixed with 1ml Montanide ISA 51 and 100mcg Granulocyte-macrophage colony-stimulating factor (GM-CSF) in a total volume of 2ml:
Immunization with the peptide pools will be given as 200 microliter intradermal and 1.8ml subcutaneously in opposite thighs. |
Biological: WT1 derived peptides
WT1 derived peptides consisting of 0.3mg (cohort 1) or 1mg (cohort 2) of each of the following peptides mixed with 1ml Montanide ISA 51 and 100mcg GM-CSF in a total volume of 2ml:
Immunization with the peptide pools will be given as 200 microliter intradermal and 1.8ml subcutaneously in opposite thighs. |
- Safety and Feasibility [ Time Frame: 2 years ]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.
- Immune Response [ Time Frame: 2 years ]To evaluate the immune response to immunizations.
- Efficacy (PFS and OS) [ Time Frame: 2 years ]To obtain preliminary data on efficacy (PFS and OS) following immunization in those with available data.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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+.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672152
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Michael A Morse, MD | Duke University | |
Study Director: | Amy Hobeika, PhD | Duke University | |
Principal Investigator: | Nelson Chao, MD | Duke University |
Responsible Party: | Michael Morse, MD, Professor of Medicine, Duke University Medical Center |
ClinicalTrials.gov Identifier: | NCT00672152 History of Changes |
Other Study ID Numbers: |
Pro00001360 |
First Posted: | May 6, 2008 Key Record Dates |
Last Update Posted: | December 10, 2013 |
Last Verified: | December 2013 |
Keywords provided by Michael Morse, MD, Duke University Medical Center:
Autologous transplantation Allogeneic transplantation |
Additional relevant MeSH terms:
Leukemia Neoplasms Myelodysplastic Syndromes Preleukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Acute |
Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders |