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Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical research trials and Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia. Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia  Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
For Condition: adult acute lymphoblastic leukemia in remission,childhood acute lymphoblastic leukemia in remission
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's tissues. Mycophenolate mofetil, cyclosporine, and donor white blood cells may prevent this rejection. PURPOSE: Phase I/II trial to study the effectiveness of donor peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine the 1-year disease-free survival of patients with high-risk acute lymphoblastic leukemia in complete remission treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation from HLA-matched unrelated donors. - Determine the day 200 transplant-related mortality in patients treated with this regimen. - Determine the efficacy of donor lymphocyte infusions (DLI) in patients treated with this regimen. - Determine the toxicity of DLI in patients treated with this regimen. 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 at 3, 6, 12, 18, and 24 months. PROJECTED ACCRUAL: A total of 30 patients (20 adults and 10 children) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of high-risk adult or pediatric acute lymphoblastic leukemia (ALL) - Age 65 to 75 in complete remission (CR) 1 or greater - Age 18 to 64 in CR 1 or greater and ineligible for or refused conventional allogeneic transplantation - CR is defined as: - Less than 5% blasts by morphology on a bone marrow biopsy and absence of peripheral blasts - High-risk adult ALL in CR1 defined as 1 or more of the following: - 30 years of age or over - Non T-cell phenotype - Cytogenetic abnormalities (e.g., t(9;22), t(4;11), trisomy 8, or monosomy 7) - Failure to achieve CR after 4 weeks of induction chemotherapy - Under 18 years of age in CR 1 or greater and ineligible for conventional allogeneic transplantation - High-risk pediatric ALL in CR1 defined as 1 or more of the following: - Cytogenic abnormalities (e.g., t(9;22) with WBC at least 25,000/mm3 at diagnosis, t(4;11) if under 1 year of age or 10 years of age and over, hypodiploidy (less than 45 chromosomes)) - Failure to achieve CR after 4 weeks of induction chemotherapy - Persistent peripheral blasts after 1 week of induction chemotherapy - No active CNS disease - Must have unrelated donor matched for HLA-A, -B, -C, -DRB1, and -DQB1 PATIENT CHARACTERISTICS: Age: - See Disease Characteristics - 75 and under Performance status: - Karnofsky 50-100% (17 years of age and over) - Lansky 40-100% (under 17 years of age) Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - No fulminant liver failure - No alcoholic hepatitis - No hepatic encephalopathy grade 2 or greater - No hepatic synthetic dysfunction - No prolongation of PT - INR less than 2.5 - No intractable ascites related to portal hypertension - No chronic viral hepatitis or biliary obstruction AND - Bilirubin no greater than 5 mg/dL - No concurrent symptomatic biliary disease - No bacterial or fungal liver abscess Renal: - Not specified Cardiovascular: - Cardiac ejection fraction at least 30% Pulmonary: - No requirement for supplementary continuous oxygen Other: - HIV negative - No history of bleeding esophageal varices - Not pregnant or nursing - Fertile patients must use effective contraception during and for 12 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeGeorges, Study Chair, Fred Hutchinson Cancer Research Center
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Richard Maziarz 503-494-6345
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting George Georges 206-667-4692
Additional Information:
Study ID Numbers: CDR0000069212; NCI-H02-0085,FHCRC-1623.00
Study Start Date:
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031655
Other Adult Acute Lymphoblastic Leukemia In Remission Studies:
1. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
2. Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
3. Monoclonal Antibody Therapy, Cyclophosphamide, and Total-Body Irradiation Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Recurrent Acute Lymphocytic Leukemia
4. Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
5. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Children With Acute Lymphoblastic Leukemia
Related Studies:
Other adult acute lymphoblastic leukemia in remission Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
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