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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00469820 |
RATIONALE: Vaccines made from the patient's cancer cells may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocyte infusion after a stem cell transplant from the patient's brother or sister may kill any cancer cells that remain after transplant.
PURPOSE: This clinical trial is studying the side effects, best dose, and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem cell transplant.
Condition | Intervention |
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Leukemia Multiple Myeloma and Plasma Cell Neoplasm |
Biological: autologous tumor cell vaccine Biological: peripheral blood lymphocyte therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant |
Estimated Enrollment: | 30 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo collection of tumor cells for production of the cancer cell vaccine and then undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation (HSCT). Patients then receive cancer cell vaccine with or without donor lymphocyte infusion. The donor lymphocytes are obtained from the same relative who donated stem cells for the HSCT.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of 1 of the following:
Acute myeloid leukemia (AML), meeting any of the following criteria:
Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Carol A. Huff, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000543531, JHOC-J06118 |
Study First Received: | May 3, 2007 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00469820 History of Changes |
Health Authority: | Unspecified |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia |
secondary acute myeloid leukemia stage III multiple myeloma untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia stage I multiple myeloma stage II multiple myeloma refractory multiple myeloma |
Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases Paraproteinemias Leukemia, Myeloid Hemostatic Disorders Leukemia, Myeloid, Acute Recurrence |
Multiple Myeloma Leukemia Lymphatic Diseases Acute Myelocytic Leukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Neoplasm Metastasis Congenital Abnormalities Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia Neoplasms, Plasma Cell |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Leukemia, Myeloid |
Hemostatic Disorders Leukemia, Myeloid, Acute Multiple Myeloma Leukemia Lymphatic Diseases Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |