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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00031655 |
Purpose
RATIONALE: Giving 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of donor peripheral stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Unrelated Donors for Treatment of Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2001 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation on day 0 followed by allogeneic peripheral blood stem cell infusion. Patients also receive oral cyclosporine twice daily on days -3 to 100 with a taper from day 101-177 and oral mycophenolate mofetil 3 times daily on days 0-40 with a taper from day 41-96.
Beginning 1-2 weeks after withdrawal of immunosuppression, patients with no evidence of acute graft-vs-host disease grade 2 or greater and no morphological disease progression may receive up to 3 donor lymphocyte infusions (DLI) IV over 30 minutes.
Patients are followed monthly for 4 months, at 6, 12, 18, and 24 months, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 30 patients (20 adults and 10 children) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of adult or pediatric acute lymphoblastic leukemia (ALL)
Age 18 to 49 with high-risk disease in CR1 OR disease in CR2 or greater and ineligible for or refused conventional allogeneic transplantation
CR is defined as:
= 30 years of age or over
Failure to achieve CR after 4 weeks of induction chemotherapy
Under 18 years of age with high-risk disease in CR1 OR disease in CR2 or greater and ineligible for conventional allogeneic transplantation
Persistent peripheral blasts after 1 week of induction chemotherapy
Must have unrelated donor matched for HLA-DRB1 and -DQB1 by high-resolution typing
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No active nonhematologic malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | George Georges, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000069212, FHCRC-1623.00, NCI-H02-0085 |
| Study First Received: | March 8, 2002 |
| Last Updated: | July 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031655 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia in remission |
|
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Vidarabine Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Mycophenolic Acid Antibiotics, Antineoplastic Cyclosporins Leukemia Antifungal Agents |
Therapeutic Uses Mycophenolate mofetil Dermatologic Agents Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Enzyme Inhibitors Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine |