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Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome Clinical research trials and Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome. Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome  Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome
Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome
For Condition: de novo myelodysplastic syndromes,previously treated myelodysplastic syndromes,Essential Thrombocythemia,secondary myelodysplastic syndromes,Polycythemia Vera,chronic idiopathic myelofibrosis
Status: Recruiting
Sponsor(s): Baylor College of Medicine ,
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells reject the body's normal tissues. Alemtuzumab may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of combining low-dose total-body irradiation and fludarabine with alemtuzumab followed by allogeneic stem cell transplantation in treating patients who have myeloproliferative disorder or myelodysplastic syndrome.
Details: OBJECTIVES: Primary - Determine the safety and feasibility of a submyeloablative conditioning regimen comprising low-dose total body irradiation, fludarabine, and alemtuzumab in patients receiving allogeneic stem cell infusion for myeloproliferative disorders or myelodysplastic syndromes, as defined by non-relapse mortality and graft rejection at day 100 after transplantation. Secondary - Determine complete remission at day 100 in patients treated with this regimen. - Determine 1-year disease-free survival in patients treated with this regimen. OUTLINE: This is a multicenter study. - Conditioning: Patients undergo low-dose total body irradiation on day -6. Patients receive fludarabine IV over 30 minutes and alemtuzumab IV over 2 hours on days -5 to -2. - Transplantation: Allogeneic stem cells are infused on day 0. Patients are followed monthly for 1 year, then every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /69 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Myelodysplastic syndromes with International Prognostic Scoring System score greater than 0 - One of the following myeloproliferative disorders: - Primary myelofibrosis with Lile score of 1 or 2 - Polycythemia vera (PV) or essential thrombocythemia transformed to acute myeloid leukemia or myelofibrosis and PV "spent phase" - No chronic myelogenous leukemia - Available 5/6 or 6/6 related or unrelated (molecular typing for DRB1) healthy donor - No active CNS disease from hematologic disorder PATIENT CHARACTERISTICS: Age - Under 70 Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - No active hepatitis - No cirrhosis - Bilirubin no greater than 3 times normal - SGOT and SGPT no greater than 3 times normal Renal - No dependence on hemodialysis Cardiovascular - No unstable angina - No uncompensated congestive heart failure - No unstable cerebral vascular disease - No hemorrhagic stroke within the past 6 months Pulmonary - No severe chronic pulmonary disease requiring oxygen Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - HIV negative - No concurrent uncontrolled infection - No concurrent solid organ malignancy not in remission, except stage 0 or A prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
UdayPopat, Study Chair, Baylor College of Medicine
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Uday Popat 713-394-6250
Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting George Carrum 713-394-6250
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Robert Krance 832-824-4661
Additional Information:
Study ID Numbers: CDR0000328132; BCM-H-10857
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069992
Other Chronic Idiopathic Myelofibrosis Studies:
1. Thalidomide in Treating Patients With Myelodysplastic Syndrome
2. Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
3. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
4. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
5. Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome
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Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome
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