|
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome Clinical research trials and Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome  Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
For Condition: Refractory Anemia,Myeloid Leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Drugs such as cyclosporine may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or myelodysplastic syndrome.
Details: OBJECTIVES: I. Determine the incidence of nonrelapse mortality at 100 days after allogeneic peripheral blood stem cell transplantation in patients with chronic myelogenous leukemia (CML) or myelodysplastic syndrome (MDS) treated with fludarabine and busulfan. II. Determine the incidence of donor stem cell engraftment in patients treated with this regimen. III. Determine the incidence and severity of acute graft-vs-host disease in patients treated with this regimen. IV. Determine the incidence of persistent or recurrent CML or MDS in patients treated with this regimen. V. Determine the safety of this regimen in these patients. PROTOCOL OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -9 to -6 and oral busulfan every 6 hours on days -5 to -2. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine orally or IV twice daily on days -1 to 100 followed by a taper until day 180. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of chronic myelogenous leukemia (CML) (BCR/abl or Philadelphia (Ph) chromosome positive); Accelerated phase More than 10% and less than 30% myeloblasts and promyelocytes in marrow or peripheral blood; Perturbations of white count, platelet count, or hematocrit uncontrolled by chemotherapy with busulfan or hydroxyurea; Progressive splenomegaly refractory to chemotherapy; Extramedullary tumor; Presence of a nonconstitutional cytogenetic abnormality in addition to a single Ph chromosome, except for: Persistent unexplained fever or bone pain; Blast phase; More than 30% myeloblasts and promyelocytes in marrow or peripheral blood; Remission after blast phase; Less than 10% blasts in marrow and peripheral blood with a history of blast phase; Any phase of CML if there is a contraindication to conditioning therapy with cyclophosphamide OR Diagnosis of myelodysplastic syndrome (MDS) with any of the following subtypes: Refractory anemia (RA) or RA with ringed sideroblasts (RARS); High-risk cytogenetics (i.e., monosomy 7 or complex abnormalities); RA with excess blasts (RAEB); Presence of 5-20% blasts in marrow and less than 5% blasts in peripheral blood; RAEB in transformation 21-30% blasts in marrow OR more than 5% blasts in peripheral blood; Chronic myelomonocytic leukemia; Presence of no more than 20% blasts in marrow, less than 5% blasts in peripheral blood, and more than 1,000 monocytes/uL of peripheral blood; Secondary acute myeloid leukemia arising from pre-existing MDS; More than 30% blasts in marrow; Any stage of MDS if there is a contraindication to conditioning therapy with cyclophosphamide - Related or unrelated donor compatible for HLA-A, B, C, DRB1, and DQB1 antigens; Mismatch for a single HLA-A, B, C, DRB1, and DQB1 allele within the same broad serotype (e.g., A*0101 vs 0102) or crossover group (e.g., A*0101 vs 0301) allowed --Prior/Concurrent Therapy-- - See Disease Characteristics - No concurrent growth factors during methotrexate administration --Patient Characteristics-- - Age: 65 and under - Performance status: Not specified - Life expectancy: Not severely limited by diseases other than malignancy - Hematopoietic: See Disease Characteristics - Hepatic: No hepatic disease; AST no greater than 2 times normal - Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 50% for age, weight, and height - Cardiovascular: No cardiac insufficiency requiring treatment; No symptomatic coronary artery disease - Pulmonary: No severe hypoxemia (pO2 less than 70 mm Hg and DLCO less than 70% predicted); No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less than 60% predicted) - Other: HIV negative; Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ClaudioAnasetti, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000069094; FHCRC-1519.00,NCI-H01-0082
Study Start Date: October 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027924
Other Myeloid Leukemia Studies:
1. Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
2. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
3. Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome
4. Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
5. Infliximab in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other Myeloid Leukemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
|
|
|
|
|
|
|
|
