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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: | NCT00036738 |
Purpose
RATIONALE: Giving imatinib mesylate, dasatinib, or nilotinib low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine and total-body irradiation followed by donor peripheral stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib.
| Condition | Intervention | Phase |
|
Leukemia |
Drug: cyclosporine Drug: dasatinib Drug: fludarabine phosphate Drug: imatinib mesylate Drug: mycophenolate mofetil Drug: nilotinib Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Drug Information available for: | Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin Imatinib Imatinib mesylate Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Dasatinib Tyrosine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive PH+ Acute Leukemia - A Multi-Center Trial |
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2001 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate, dasatinib, or nilotinib once daily beginning before study and continuing until day -2 of study. Patients resume oral imatinib mesylate, dasatinib, or nilotinib once daily beginning on day 14 or when blood counts recover after peripheral blood stem cell (PBSC) transplantation.
Patients with persistent disease and no GVHD after stopping GVHD prophylaxis receive donor lymphocyte infusion IV over 30 minutes once every 28 days for 3 doses.
Patients are followed at 6, 9, 12, 18, and 24 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 5 years.
Eligibility
| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) or chronic myelogenous leukemia in blast crisis
Less than 15% blasts on morphologic bone marrow evaluation after receiving imatinib mesylate, dasatinib, or nilotinib
Availability of an HLA-matched related or unrelated peripheral blood stem cell donor
Related donors HLA genotypically identical for at least 1 haplotype and may be genotypically or phenotypically identical for HLA-A, -B, -C, -DRB1, and -DQB1 alleles
Unrelated donors meeting the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Colorado | |||||
| Rocky Mountain Cancer Centers - Denver Midtown | Recruiting | ||||
| Denver, Colorado, United States, 80218 | |||||
| Contact: Michael B. Maris, MD 303-388-4876 | |||||
| United States, Washington | |||||
| Fred Hutchinson Cancer Research Center | Recruiting | ||||
| Seattle, Washington, United States, 98109-1024 | |||||
| Contact: George Georges, MD 206-667-6886 ggeorges@fhcrc.org | |||||
| Seattle Cancer Care Alliance | Recruiting | ||||
| Seattle, Washington, United States, 98109-1023 | |||||
| Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |||||
| Veterans Affairs Medical Center - Seattle | Recruiting | ||||
| Seattle, Washington, United States, 98108 | |||||
| Contact: Thomas R. Chauncey, MD, PhD 206-764-2709 | |||||
| Fred Hutchinson Cancer Research Center |
| National Cancer Institute (NCI) |
| Study Chair: | George Georges, MD | Fred Hutchinson Cancer Research Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Norasetthada L, Maris MB, Sandmaier BM, et al.: Feasibility and toxicity of nonmyeloablative hematopoietic cell transplantation (HCT) with or without imatinib for Philadelphia chromosome (Ph+) acute lymphoblastic leukemia (ALL). [Abstract] Blood 104 (11): A-5056, 2004.
  |
| Responsible Party: | Fred Hutchinson Cancer Research Center ( George Georges ) |
| Study ID Numbers: | CDR0000069315, FHCRC-1581.00, NCI-H02-0087 |
| First Received: | May 13, 2002 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00036738 |
| Health Authority: | Unspecified |
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