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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052520 |
RATIONALE: Biological therapies work in different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells in patients undergoing donor stem cell transplantation.
PURPOSE: This phase I/II trial is studying the side effects of biological therapy and to see how well it works in treating patients with advanced chronic myeloid leukemia, acute myeloid leukemia, or acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: aldesleukin Drug: therapeutic allogeneic lymphocytes |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Study Of Adoptive Immunotherapy With CD8+ WT1-Specific CTL Clones for Patients With Advanced MDS, CML, AML or ALL After Allogeneic Hematopoietic Stem Cell Transplant |
Estimated Enrollment: | 15 |
Study Start Date: | September 2002 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Highest-risk disease group: Experimental
Patients receive CD8-positive Wilms' tumor (WT1) gene-specific CTL clones IV over 1-2 hours on days 0, 14, and 28. Patients receive interleukin-2 subcutaneously twice daily on days 28-42 in the absence of unacceptable toxicity.
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Drug: aldesleukin
Given subcutaneously
Drug: therapeutic allogeneic lymphocytes
Given IV
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Relapsed-disease group: Experimental
Some patients with morphologic evidence of leukemic relapse may receive standard salvage chemotherapy prior to donor CTL infusions and then receive CD8-positive Wilms' tumor (WT1) gene-specific CTL clones and interleukin-2 as in the highest-risk group.
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Drug: aldesleukin
Given subcutaneously
Drug: therapeutic allogeneic lymphocytes
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Donors undergo leukapheresis for stem cell harvest to generate CD8-positive Wilms' tumor (WT1) gene-specific cytotoxic T-lymphocyte (CTL) clones at the time of allogeneic stem cell transplantation.
After post-transplantation hematopoietic recovery, patients receive treatment for either highest-risk disease (prophylactically) or relapsed disease.
Patients in both groups who have progressive disease after complete or partial response to therapy may be eligible for retreatment with CD8-positive Wilms' tumor (WT1) gene-specific CTL clones.
Blood samples may be collected monthly and patients may undergo a bone marrow biopsy every 3 months. Samples are analyzed for WT1 specific T cells via multimer staining and flow cytometric analysis; functional anti-WT1 activity; other immunological parameters; WT 1 expression; and potential genetic markers. In addition samples may be assessed by morphology, flow cytometry, PCR or cytogenetic analysis.
After completion of study treatment, patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 10-15 patients will be accrued for this study within 3-5 years.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planned allogeneic stem cell transplantation for one of the following diagnoses:
Acute leukemia at any stage arising from myelodysplastic or myeloproliferative syndromes, including:
No grade III or IV graft-versus-host disease unresponsive to therapy or requiring therapy with any of the following:
Relapsed-disease group: One of the following types of relapsed disease after transplantation:
Morphologic relapse defined by one or more of the following:
Molecular relapse defined as one of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Concurrent immunosuppressive therapy for graft-versus-host disease (GVHD) allowed if meets 1 of the following criteria:
Radiotherapy
Surgery
Other
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Gunnar Ragnarsson, MD, MSC 206-667-5918 gunnib@u.washington.edu | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Study Chair: | Gunnar Ragnarsson, MD, MSC | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Gunnar Ragnarsson ) |
Study ID Numbers: | CDR0000258507, FHCRC-1655.00 |
Study First Received: | January 24, 2003 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00052520 |
Health Authority: | Unspecified |
recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia B-cell adult acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia recurrent childhood acute lymphoblastic leukemia adult acute myeloid leukemia with t(8;21)(q22;q22) |
adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) childhood chronic myelogenous leukemia relapsing chronic myelogenous leukemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts childhood myelodysplastic syndromes |
Leukemia, Lymphoid Precancerous Conditions Chronic myelogenous leukemia Refractory anemia Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Wilms Tumor Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Lymphoma |
Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Wilms' tumor Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Anemia Myeloproliferative Disorders Leukemia, Myeloid Recurrence Lymphatic Diseases Aldesleukin Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Anti-Infective Agents Neoplasms by Histologic Type Disease Anti-HIV Agents Immune System Diseases Antineoplastic Agents Antiviral Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Anti-Retroviral Agents Syndrome Therapeutic Uses |