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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052520 |
Purpose
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 |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Biological: aldesleukin Biological: 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 |
|---|---|
|
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.
|
Biological: aldesleukin
Given subcutaneously
Biological: therapeutic allogeneic lymphocytes
Given IV
|
|
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.
|
Biological: aldesleukin
Given subcutaneously
Biological: therapeutic allogeneic lymphocytes
Given IV
|
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 receive interleukin-2 subcutaneously twice daily on days 28-42 in the absence of unacceptable toxicity.
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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Responsible Party: | Fred Hutchinson Cancer Research Center ( Gunnar Ragnarsson ) |
| Study ID Numbers: | CDR0000258507, FHCRC-1655.00 |
| Study First Received: | January 24, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052520 History of Changes |
| 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 |
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Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Precancerous Conditions Leukemia, Myeloid, Acute Refractory Anemia Leukemia Acute Myelocytic Leukemia Preleukemia Anemia, Refractory Anti-Retroviral Agents Acute Myeloid Leukemia, Adult Wilms' Tumor Neoplasm Metastasis Wilms Tumor Congenital Abnormalities |
Lymphoma Acute Lymphoblastic Leukemia Anti-HIV Agents Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Myelodysplastic Syndromes Anemia Myeloproliferative Disorders Leukemia, Myeloid Antiviral Agents Recurrence Acute Myeloid Leukemia, Childhood Lymphatic Diseases Aldesleukin |
|
Anti-Infective Agents Leukemia, Lymphoid Precancerous Conditions Antineoplastic Agents Leukemia Preleukemia Pathologic Processes Anti-Retroviral Agents Syndrome Therapeutic Uses Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Disease |
Anti-HIV Agents Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Antiviral Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Aldesleukin Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Bone Marrow Diseases |