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Bone Marrow Transplantation in Treating Patients With Hematologic Cancers Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Bone Marrow Transplantation in Treating Patients With Hematologic Cancers conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Bone Marrow Transplantation in Treating Patients With Hematologic Cancers Clinical research trials and Bone Marrow Transplantation in Treating Patients With Hematologic Cancers health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Bone Marrow Transplantation in Treating Patients With Hematologic Cancers. Bone Marrow Transplantation in Treating Patients With Hematologic Cancers Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Bone Marrow Transplantation in Treating Patients With Hematologic Cancers clinical trial. Human subjects often get the best healthcare possible for their Bone Marrow Transplantation in Treating Patients With Hematologic Cancers condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bone Marrow Transplantation in Treating Patients With Hematologic Cancers  Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
For Condition: chronic leukemia,chronic myeloproliferative disorders,plasma cell neoplasm,acute leukemia,myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of donor bone marrow transplantation in treating patients who have hematologic cancers.
Details: OBJECTIVES: - Determine the progression free survival (PFS) and overall survival (OS) of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation (BMT). - Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide, total body irradiation, and allogeneic BMT. - Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients. - Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia. OUTLINE: - Regimen A: Patients with chronic myelogenous leukemia (CP1, AP/CP2) and other myeloproliferative disorders, myelodysplastic disorders, acute myelogenous leukemia (CR1), or multiple myeloma (not eligible to receive total body irradiation due to prior radiation) are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation (BMT). Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Allogeneic bone marrow is infused on day 0. - Regimen B: Patients with acute myelogenous leukemia (at least CR2, relapsed), acute lymphoid leukemia (ALL), any acute leukemia with CNS involvement, multiple myeloma, or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT. Patients receive total body irradiation (TBI) on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3. Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI. Allogeneic bone marrow is infused on day 0. Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis. Patients are followed weekly for 3 months and then monthly for 1 year. PROJECTED ACCRUAL: At least 50 patients with low risk myeloid disease, 50 patients with lymphoid malignancies, and 60 patients with high risk myeloid disease will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of: - Acute myelogenous leukemia - Complete remission (CR) 1 - ALL except good cytogenetics defined as [(inv16, t(8,21), t(15,17)] - CR2 - Induction failures - Relapsed OR - Acute lymphocytic leukemia (ALL) - CR1 - high risk defined as overt CNS involvement, 1 or more risk factors (age 30 and over, WBC at least 20,000/mm^3, at least 4 weeks to CR1, myeloid phenotype) - CR2 - Induction failures - Relapsed OR - Chronic myelogenous leukemia - Chronic phase (CP) 1 - Accelerated phase (AP)/CP2 OR - Chronic lymphocytic leukemia - At diagnosis - RAI stage III/IV or Binet C - Must undergo 1 induction regimen - Relapsed - any stage - Must have received no more than 3 regimens for diagnosis OR - Multiple myeloma - At diagnosis - stage II/III (primary refractory or sensitive) - Relapsed no more than 2 times - sensitive disease - Plasma cell leukemia OR - Myelodysplasia - All subtypes eligible OR - Myeloproliferative disorders - Poor response to medical therapy OR - Cytogenetic abnormalities - Must have a related donor who is genotypic 6 out of 6 HLA A, B, and DR match - Molecular DR matching required PATIENT CHARACTERISTICS: Age: - 15 to 55 Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 3 times upper limit of normal - PT/PTT normal Renal: - Creatinine no greater than 2.0 mg/dL - Creatinine clearance at least 60 mL/min Cardiovascular: - LVEF at least 45% by MUGA scan or echocardiography - No myocardial infarction within the past 6 months - No arrhythmias controlled by therapy Pulmonary: - FEV_1 at least 50% predicted - DLCO at least 50% predicted Other: - Not pregnant or nursing - Negative pregnancy test - No diabetes mellitus or thyroid disease that is not medically controlled - No psychosocial disorder that would preclude study compliance - No active serious infections - HIV negative - Donor must be HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenGoldstein, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Teresa Field 813-979-7202
Additional Information:
Study ID Numbers: CDR0000067767; MCC-11281,MCC-IRB-4188,NCI-G00-1759
Study Start Date:
Record last reviewed: October 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005797
Other Chronic Myeloproliferative Disorders Studies:
1. 3-AP and Cytarabine in Treating Patients With Hematologic Cancer
2. T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia
3. 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
4. Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
5. VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome
Related Studies:
Other chronic myeloproliferative disorders Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
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