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Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome Clinical research trials and Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome clinical trial. Test subjects typically receive the most expert healthcare available for their Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome  Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
For Condition: childhood acute myeloid leukemia and other myeloid malignancies,myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia,Chronic Myelomonocytic Leukemia,adult acute monocytic leukemia,adult acute myeloid leukemia
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer 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. Combining chemotherapy with donor bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome.
Details: OBJECTIVES: - Determine the remission duration, disease-free survival, and overall survival of patients with acute myelogenous leukemia in remission or early relapse or myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation. OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic bone marrow is infused on day 0. Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow infusion on day 0. All patients receive prophylaxis for graft versus host disease. Patients are followed every 6 months for at least 2 years. PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) acute myelogenous leukemia or myelodysplastic syndrome of 1 of the following subtypes: - Acute myeloblastic leukemia (M1, M2) - Acute promyelocytic leukemia (M3) - Acute myelomonocytic leukemia (M4) - Acute monocytic leukemia (M5) - Acute erythroleukemia (M6) - Acute megakaryocytic leukemia (M7) - Refractory anemia - Refractory anemia with excess blasts - Refractory anemia with excess blasts in transformation - Refractory anemia with ringed sideroblasts - Chronic myelomonocytic leukemia - In remission or in early relapse as defined by less than 20% blast cells in the marrow or overt active acute myeloid leukemia - Suitable marrow donor, defined as a sibling donor matched at the HLA-A, HLA-B, and HLA-D/DR locus nonreactive in bidirectional mixed lymphocyte culture or a donor who is mismatched at 1 antigen loci - Active CNS disease allowed PATIENT CHARACTERISTICS: Age: - 16 to physiologic 60 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 3 times upper limit of normal (ULN) unless due to Gilbert's disease - SGOT no greater than 3 times ULN Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - Cardiac ejection fraction normal Pulmonary: - FEV_1 at least 50% of predicted - DLCO at least 50% of predicted Other: - HIV negative - No evidence of persistent infection - No concurrent organ damage or medical problems that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent antibiotics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinTallman, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Martin Tallman 312-695-4540
Additional Information:
Study ID Numbers: CDR0000067575; NU-91H4T,NCI-G00-1686
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004896
Other Atypical Chronic Myeloid Leukemia Studies:
1. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
2. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
3. Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes
4. Chemotherapy in Treating Children With Down Syndrome Plus Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
5. Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
Related Studies:
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Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
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