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Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid 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 Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia Clinical research trials and Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid 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 Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia. Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid 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 Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid 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 > "B" Clinical Trials Conditions > Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia  Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia
Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,refractory chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,Philadelphia chromosome negative chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins Oncology Center
Synopsis: RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow and may help a person's immune system recover from the side effects of the chemotherapy used in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation, chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.
Details: OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow transplantation followed by GM-CSF and interferon alfa. II. Determine the toxicity of this regimen in these patients. PROTOCOL OUTLINE: Patients undergo harvesting of autologous bone marrow. A portion of the cells are treated ex vivo with sargramostim (GM-CSF) for 3 days. Patients then receive myeloablative chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the preparative regimen protocol. Patients undergo sargramostim (GM-CSF)-treated autologous bone marrow transplantation on day 0. Patients receive GM-CSF subcutaneously daily on days 5-180, and interferon alfa daily on days 90-180. Patients are followed monthly for 1 year, every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 9-19 patients will be accrued for this study within 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of chronic phase chronic myeloid leukemia (CML) by cytogenetic and/or molecular analyses; No more than 10% blasts on blood and bone marrow morphology; Philadelphia (Ph) chromosome positive; Ph chromosome-negative CML allowed if evidence of the BCR-ABL rearrangement by molecular or FISH analyses or evidence of the P120 protein - Duration of CML less than 3 years, unless cytogenetic remission to interferon has been achieved - Failed to obtain and maintain a complete cytogenetic remission on a prior trial of interferon therapy; Absence of detectable PH-negative cells in bone marrow or blood after 6 months of therapy; Lack of a progressive increase in Ph-negative cells between 6 and 12 months of therapy; Less than 50% Ph-negative cells after 12 months of therapy; Absence of complete cytogenetic remission after 24 months of therapy; Inability to tolerate prior interferon therapy - No accelerated phase or blast crisis CML, chronic myelomonocytic leukemia, or juvenile CML - Concurrent enrollment on the busulfan and cyclophosphamide preparative regimen protocol --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: 12 to 70 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: No history of intolerance to sargramostim (GM-CSF)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
B.Smith, Study Chair, Johns Hopkins Oncology Center
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: CDR0000068460; IMMUNEX-001.0683,JHOC-98051405,NCI-G01-1912,JHOC-J9833
Study Start Date: May 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011934
Other Refractory Chronic Myelogenous Leukemia Studies:
1. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
2. Interferon alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
3. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
4. Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia
5. Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other refractory chronic myelogenous leukemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia
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