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Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate Clinical research trials and Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate clinical trial. Subjects frequently obtain the most expert healthcare possible for their Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate  Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
For Condition: childhood chronic myelogenous leukemia,recurrent adult acute lymphoblastic leukemia,blastic phase chronic myelogenous leukemia,recurrent childhood acute lymphoblastic leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Combining imatinib mesylate with fludarabine and total-body irradiation followed by donor peripheral stem cell transplantation may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine and total-body irradiation followed by donor peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate.
Details: OBJECTIVES: - Determine whether the rate of leukemic relapse and transplant-related mortality can be decreased for patients with imatinib mesylate-responsive Philadelphia chromosome-positive acute lymphoblastic leukemia or blast crisis chronic myelogenous leukemia treated with a non-myeloablative conditioning regimen comprising fludarabine and total body irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT), compared to historical controls treated with high-dose conventional chemotherapy followed by allogeneic PBSCT. - Evaluate whether donor lymphocyte infusions can be safely used in patients with mixed or full donor chimerism as preemptive therapy to eliminate minimal residual disease. - Determine the leukemia-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive imatinib mesylate once daily beginning before study and continuing until day -2 of study. Patients resume imatinib mesylate once daily beginning on day 14 or when blood counts recover after PBSCT. - Transplantation: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV on days -4 to -2 and total body irradiation followed by filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. - Graft-versus-host-disease (GVHD) prophylaxis: Patients receiving related PBSC receive oral mycophenolate mofetil (MMF) twice daily on days 0-27 without tapering. Patients receiving unrelated PBSC receive MMF three times daily on days 0-40 and then tapered on days 41-96 in the absence of GVHD or disease progression. Adults receiving related PBSC receive cyclosporine (CYSP) orally twice daily on days -3 to 56 and then tapered on days 57-100. Children receiving related donor PBSC receive CYSP IV every 8 or 12 hours on days -3 to 56 and then tapered on days 57-100. Adults receiving unrelated donor PBSC receive oral CYSP twice daily on days -3 to 100 and then tapered on days 101-177. Children receiving unrelated donor PBSC receive CYSP IV every 8 or 12 hours on days -3 to 100 and then tapered on days 101-177. - CNS prophylaxis: Patients receive six doses of intrathecal methotrexate or cytarabine beginning on day 32 after PBSCT or when there is no evidence of gross systemic leukemia. Patients who have a history of CNS leukemia at any time and have not received prior cranio-spinal irradiation (CSI) before study entry receive CSI for 11 days after PBSCT when there is no evidence of gross systemic leukemia. Patients with persistent disease and no GVHD after stopping GVHD prophylaxis receive donor lymphocyte infusion once every 28 days for 3 doses. Patients are followed at 6 months and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of refractory or relapsed Philadelphia chromosome-positive acute lymphoblastic leukemia or blast crisis chronic myelogenous leukemia - Morphologic or minimal residual disease - Less than 15% blasts on morphologic bone marrow evaluation after receiving imatinib mesylate (STI571) - Patients who initially respond to STI571 and then progress are ineligible - No CNS involvement with leukemia refractory to intrathecal chemotherapy - 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 - No identical twin OR - Unrelated donors meeting the following criteria: - Matched for HLA-DRB1 and DQB1 alleles - Matched for serologically detectable HLA-A, -B, or -C antigen - Matched for any combination of 2 or more HLA-A, -B, or -C alleles PATIENT CHARACTERISTICS: Age: - 70 and under - Patients age 12 and under are allowed at the discretion of the protocol investigator Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if leukemic involvement of liver suspected) - AST and ALT no greater than 2.5 times ULN (5 times ULN if leukemic involvement of liver suspected) - No fulminant liver failure - No cirrhosis of the liver with evidence of portal hypertension - No alcoholic hepatitis - No prior bleeding esophageal varices - No concurrent esophageal varices - No hepatic encephalopathy - No uncorrectable hepatic synthetic dysfunction, evidenced by prolongation of PT - No ascites related to portal hypertension - No bacterial or fungal liver abscess - No biliary obstruction - No chronic viral hepatitis (with bilirubin greater than 3 mg/dL) - No symptomatic biliary disease Renal: - Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: - No greater than grade II hypertension - No poorly controlled hypertension despite multiple antihypertensives - No grade III or IV cardiac disease Pulmonary: - DLCO at least 40% predicted - No requirement for continuous supplementary oxygen Other: - Not pregnant or nursing - Fertile patients must use effective barrier contraception during and for 1 year after study participation - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 48 hours since prior interferon alfa Chemotherapy: - See Disease Characteristics - At least 24 hours since prior hydroxyurea - At least 14 days since prior homoharringtonine - At least 7 days since prior low-dose cytarabine (less than 30 mg/m^2 every 12-24 hours) - At least 14 days since prior moderate-dose cytarabine (100-200 mg/m^2 for 5-7 days) - At least 28 days since prior high-dose cytarabine (1-3 g/m^2) every 12-24 hours for 6-12 doses - At least 21 days since prior anthracyclines, mitoxantrone, etoposide, methotrexate, or cyclophosphamide - At least 6 weeks since prior busulfan Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelMaris, Study Chair, Fred Hutchinson Cancer Research Center
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Edward Agura 214-370-1500
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Ashwin Kashyap 626-359-8111
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5623
United States
Recruiting Karl Blume 650-723-0822
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Peter McSweeney 303-372-9000
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239
United States
Recruiting Brian Druker 503-494-5596
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Dietger Niederwieser 49-341-971-3050
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Michael Maris 206-667-2480
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84132
United States
Recruiting Finn Petersen 801-585-3229
Additional Information:
Study ID Numbers: CDR0000069315; NCI-H02-0087,FHCRC-1581.00
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036738
Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
2. Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
3. Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
4. AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate
5. Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
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