|
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Clinical research trials and Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer  Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
For Condition: Previously Treated Myelodysplastic Syndrome,secondary myelodysplastic syndrome,untreated adult acute lymphoblastic leukemia,refractory plasma cell neoplasm,adult acute myeloid leukemia in remission,recurrent adult acute myeloid leukemia,recurrent adult acute lymphoblastic leukemia,adult acute lymphoblastic leukemia in remission,refractory anemia with excess blasts,untreated adult acute myeloid leukemia,chronic phase chronic myelogenous leukemia,refractory anemia with excess blasts in transformation,de novo myelodysplastic syndrome
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins Oncology Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: I. Determine the 1 year survival rate of patients with hematologic malignancies after treatment with allogeneic (HLA matched, unrelated) bone marrow transplantation following high dose chemotherapy. PROTOCOL OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone is administered IV over 1 hour on days 5-16, and is then tapered. Patients are followed every 6 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Any of the following diagnoses: Chronic myelogenous leukemia (CML) in first chronic phase OR Myelodysplastic syndrome; Refractory anemia with excess blasts (RAEB) OR RAEB in transformation OR Secondary leukemias untreated or in complete remission 1 (CR1); Acute myeloid leukemia in complete remission 2 (CR2) OR Acute lymphocytic leukemia (ALL) in CR2 OR High risk acute leukemia in CR1 OR Ph+ ALL in CR1 or as consolidation following induction chemotherapy - Must qualify for allogeneic bone marrow transplantation (BMT) - No HLA matched, sibling donor for BMT available - No current CNS disease - No history of greater than 2 episodes of active CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior autologous or allogeneic bone marrow transplantation; No prior transfusions from donor - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 19 to 55 - Performance status: ECOG 0 or 1 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2 mg/dL - Renal: Creatinine no greater than 2 mg/dL - Cardiovascular: LVEF at least 45%; No active congestive heart failure, arrhythmia, or angina pectoris; No myocardial infarction within past 12 months - Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy) - Other: No active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis); HIV negative; Not pregnant; Fertile patients must use effective contraception; No concurrent debilitating medical or psychiatric illness that would preclude compliance; No prior malignancy except curatively treated skin cancer or carcinoma of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulO'Donnell, Study Chair, Johns Hopkins Oncology Center
Center for Cancer Treatment and Research
Columbia, South Carolina, 29203
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: CDR0000067159; JHOC-98032006,NCI-G99-1543,JHOC-J9828
Study Start Date: April 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003960
Other Adult Acute Lymphoblastic Leukemia In Remission Studies:
1. Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
2. Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
3. R115777 in Treating Patients With Relapsed or Refractory Multiple Myeloma
4. Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
5. Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma
Related Studies:
Other adult acute lymphoblastic leukemia in remission Clinical Trials
Other South Carolina Clinical Trials
Other Columbia Clinical Trials
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
|
|
|
|
|
|
|
|
