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Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical research trials and Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia. Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia  Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
For Condition: childhood acute lymphoblastic leukemia in remission,adult acute lymphoblastic leukemia in remission
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and donor white blood cells may prevent this from happening. PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine if a one-year disease free survival of 40% and a day 200 transplant-related mortality of less than 25% can be achieved in patients with high-risk acute lymphoblastic leukemia in complete remission treated with a nonmyeloablative conditioning regimen comprising fludarabine and total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation. - Evaluate the efficacy and toxicity of donor lymphocyte infusion in the treatment of minimal residual disease after nonmyeloablative allografting in these patients. OUTLINE: This is a multicenter study. Patients receive a nonmyeloablative conditioning regimen comprising fludarabine IV on days -4 to -2 and total body irradiation (TBI) on day 0. Children undergo allogeneic peripheral blood stem cell transplantation (PBSCT) or bone marrow transplantation after TBI on day 0. Adults undergo filgrastim (G-CSF)-mobilized allogeneic PBSCT after TBI on day 0. Patients also receive graft-versus-host disease (GVHD) prophylaxis therapy comprising oral cyclosporine twice daily on days -3 to 56 and then tapered and oral mycophenolate mofetil once at 5-10 hours after transplantation on day 0 and then twice daily on days 1-27. Patients who have no evidence of grade 2 or greater acute GVHD or clinically extensive chronic GVHD, have been off GVHD prophylaxis therapy for 1-2 weeks, and have stable or increasing minimal residual disease after discontinuation of GVHD prophylaxis therapy receive donor lymphocyte infusion (DLI) IV over 30 minutes. DLI repeats every 4 weeks for a total of 3 doses (if necessary). Patients without a history of CNS leukemia and patients with a history of CNS leukemia previously treated with prophylactic craniospinal irradiation receive methotrexate (MTX) or cytarabine (ARA-C) intrathecally (IT) for a total of 2 doses before transplantation and for a total of 6 doses beginning on day 32 after transplantation. Patients with a history of CNS leukemia not previously treated with craniospinal irradiation undergo craniospinal irradiation for 11 days before conditioning regimen and then MTX or ARA-C IT for a total of 6 doses beginning on day 32 after transplantation. Male patients also undergo testicular radiotherapy for 7 days. Patients are followed at 1, 2, 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 acute lymphoblastic leukemia (ALL) - Adult patients must meet 1 of the following criteria: - Age 50 to 75 with high-risk ALL in complete remission (CR) (less than 5% blasts by morphology on bone marrow aspirate and absence of peripheral blasts) or ALL in second CR (CR2) or greater - Age 18 to 50 with high-risk ALL in first CR (CR1) and either ineligible for conventional allogeneic transplantation (based on general medical condition) or refused conventional transplantation - High-risk adult ALL in CR1 includes patients meeting 1 or more of the following criteria: - Age 30 and over - Non-T-cell phenotype - Cytogenetic abnormalities including t(9;22), t(4;11), trisomy 8, or monosomy 7 - Failure to achieve CR after 4 weeks of induction chemotherapy - Age 18 to 50 with ALL in CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition - Age 18 to 50 with high-risk ALL in CR2 or greater and refused conventional allogeneic transplantation - Pediatric patients must meet 1 of the following criteria: - Under age 18 with high-risk ALL in CR1 and ineligible for conventional allogeneic transplantation based on general medical condition - High-risk pediatric ALL in CR1 includes patients meeting 1 or more of the following criteria: - Cytogenetic abnormalities - t(9;22) with WBC at least 25,000/mm3 at diagnosis - t(4;11) in patients under age 1 or age 10 and over - Hypodiploidy (no more than 45 chromosomes) - Failure to achieve CR after 4 weeks of induction chemotherapy - Persistent peripheral blasts after 1 week of induction chemotherapy - Under age 18 with CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition - Age 12 and under allowed if approved by the principle investigator - No active CNS disease - Availability of a sibling donor (excluding an identical twin) - HLA genotypically identical for at least 1 haplotype - HLA-A, -B, -C, -DRB1, and -DQB1 genotypically or phenotypically identical PATIENT CHARACTERISTICS: Age: - See Disease Characteristics - 75 and under Performance status: - Karnofsky 50-100% (adults) - Lansky 40-100% (children) Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - No fulminant liver failure - No alcoholic hepatitis - No history of bleeding esophageal varices - No grade II or greater hepatic encephalopathy - No hepatic synthetic dysfunction evidenced by prolongation of PT with INR greater than 2.5 - No intractable ascites related to portal hypertension - No bacterial or fungal liver abscess - No chronic viral hepatitis with bilirubin greater than 5 mg/dL - No biliary obstruction with bilirubin greater than 5 mg/dL - No concurrent symptomatic biliary disease Renal: - Not specified Cardiovascular: - Cardiac ejection fraction at least 30% Pulmonary: - No requirement for supplementary continuous oxygen Other: - HIV negative - Not pregnant or nursing - Fertile patients must use effective contraception during and for 1 year after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent posttransplantation growth factors during mycophenolate mofetil administration Chemotherapy - See Disease Characteristics Endocrine therapy - 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
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Dietger Niederwieser 49-341-971-3050
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239
United States
Recruiting Elliot Epner 503-494-1551
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Ann Woolfrey 206-667-4453
Additional Information:
Study ID Numbers: CDR0000069042; FHCRC-1586.00,NCI-H01-0080
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027547
Other Adult Acute Lymphoblastic Leukemia In Remission Studies:
1. Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia
2. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
3. Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
4. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Children With Acute Lymphoblastic Leukemia
5. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
Related Studies:
Other adult acute lymphoblastic leukemia in remission Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
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