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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052598 |
Purpose
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining cellular adoptive immunotherapy with interleukin-2 may be effective treatment for recurrent myeloid leukemias.
PURPOSE: This phase I/II trial is studying the side effects of giving cellular adoptive immunotherapy together with interleukin-2 and to see how well it works in treating patients with recurrent myeloid leukemias after undergoing allogeneic stem cell transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: aldesleukin Biological: therapeutic allogeneic lymphocytes Procedure: adjuvant therapy Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control |
| Official Title: | Phase I/II Study Of Adoptive Immunotherapy With CD8+ Proteinase 3 (Myeloblastin)-Specific CTL Clones For HLA-A2+ Patients With Relapse Or Progression Of Disease After Allogeneic Hematopoietic Stem Cell Transplant For High-Risk Myeloid Leukemias |
| Estimated Enrollment: | 35 |
| Study Start Date: | August 2005 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, non-randomized, pilot study.
Donors undergo leukapheresis for the harvest of allogeneic blood mononuclear cells. CD8+ proteinase 3 (PR3)-specific cytotoxic T-lymphocytes (CTLs) are isolated as clones and generated ex vivo.
Patients undergo allogeneic stem cell transplantation.
Patients with relapse/progression (more than 5% leukemic blasts in marrow) after transplantation may receive cytoreductive chemotherapy before adoptive immunotherapy.
After leukemic relapse or progression*, patients receive adoptive immunotherapy comprising allogeneic CD8+ PR3-specific CTLs IV over 1-2 hours on days 0, 7, 14, 28, and 49 and interleukin-2 subcutaneously twice daily on days 28-41 and 49-62. Treatment continues in the absence of unacceptable toxicity.
Patients with disease progression or recurrence after complete or partial response to adoptive immunotherapy may be eligible to repeat treatment.
Blood samples are collected monthly and patients undergo a bone marrow biopsy every 3 months.
After completion of study treatment, patients are followed for up to 2 years.
NOTE: *Patients with > 5% morphologic blasts detectable in bone marrow or peripheral blood just prior to or at the time of transplant will receive therapy phophylactically directly after transplant.
PROJECTED ACCRUAL: A total of 15-35 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:
Diagnosis of 1 of the following high-risk myeloid leukemias:
Acute leukemia arising in a patient with an prior diagnosis of a myelodysplastic or myeloproliferative syndrome (including chronic myelomonocytic leukemia, CML, polycythemia vera, essential thrombocytosis, and agnogenic myeloid metaplasia with myelofibrosis)
Relapsed-disease group: One of the following types of relapsed disease after transplantation:
Morphologic relapse defined as at least 1 of the following:
Flow cytometric relapse
Cytogenetic relapse or progression defined by ≥ 1 of the following:
Molecular relapse or progression
No grade III or IV graft-versus-host disease unresponsive to therapy or requiring treatment with any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Concurrent immunosuppressive therapy for graft-versus-host disease (GVHD) allowed if 1 of the following:
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| 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: | CDR0000258557, FHCRC-1671.00 |
| Study First Received: | January 24, 2003 |
| Last Updated: | July 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052598 History of Changes |
| Health Authority: | United States: Federal Government |
|
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia childhood chronic myelogenous leukemia secondary acute myeloid leukemia recurrent adult acute myeloid leukemia |
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) |
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Anti-Infective Agents Leukemia Neoplasms Anti-HIV Agents Aldesleukin Neoplasms by Histologic Type |
Anti-Retroviral Agents Antineoplastic Agents Therapeutic Uses Leukemia, Myeloid Antiviral Agents Pharmacologic Actions |