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Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders 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 Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders Clinical research trials and Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders 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 Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders. Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders 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 Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders clinical trial. Test subjects typically receive the most expert healthcare available for their Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders 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 > "D" Clinical Trials Conditions > Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders  Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
For Condition: chronic leukemia,plasma cell neoplasm,chronic myeloproliferative disorders,atypical chronic myeloid leukemia,acute leukemia,myelodysplastic and myeloproliferative disease
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 total-body irradiation used to kill leukemia and lymphoma cells. Bone marrow transplantation using donated bone marrow may be an effective treatment for malignant or nonmalignant hematologic disorders. PURPOSE: Phase II trial to study the effectiveness of donor bone marrow transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.
Details: OBJECTIVES: - Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders. - Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients. - Determine the relapse rates with this treatment regimen in those patients with malignant disorders. - Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients. OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0. Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant. Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant. Patients are followed once a week for 3 months, and then monthly for 1 year. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/50 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of one of the following: - Acute lymphocytic leukemia (ALL): - Complete remission (CR) 1 - high risk defined as overt CNS involvement or poor cytogenetics (additions, deletions, translocations, or multiple abnormalities) - CR2 - Induction failures - Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt - Acute myelogenous leukemia (AML): - CR1 - high risk defined as poor cytogenetics (deletions, additions, multiple abnormalities) - CR2 - Induction failures - Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt - Chronic myelogenous leukemia (CML): - Chronic phase (CP) 1 - Accelerated phase/CP2 - patients in blast phase must undergo treatment and achieve a second chronic phase prior to transplant - Chronic lymphocytic leukemia (CLL): - Relapse - any stage; must have received no more than 3 prior regimens - Multiple myeloma: - At diagnosis - primary refractory - Relapse (no more than 2) - sensitive disease - Plasma cell leukemia - Inability to achieve a complete remission after autologous transplant (no older than 40) - Myelodysplasia - all subtypes - Myeloproliferative disorders - patients with poor response to medical therapy or cytogenetic abnormalities - Severe aplastic anemia (SAA): - Very SAA - at diagnosis - SAA - induction therapy - Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch PATIENT CHARACTERISTICS: Age: - 15 to 50 Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT and SGPT no greater than 3 times normal - PT/PTT normal Renal: - Creatinine no greater than 2.0 mg/dL - Creatinine clearance at least 60 mL/min Cardiovascular: - Left ventricular ejection fraction at least 45% - No myocardial infarction within past 6 months - No uncontrolled arrhythmias Pulmonary: - FEV1 at least 50% - DLCO at least 50% predicted Other: - No active serious infection - HIV negative - Not pregnant or nursing - No uncontrolled diabetes mellitus or thyroid disease PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics 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: CDR0000067763; MCC-11282,MCC-IRB-4189,NCI-G00-1755
Study Start Date:
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005622
Other Plasma Cell Neoplasm Studies:
1. Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
2. Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
3. Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes
4. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
5. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
Related Studies:
Other plasma cell neoplasm Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
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