|
Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria 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 Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria Clinical research trials and Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria 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 Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria. Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria 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 Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria clinical trial. Human subjects often get the best healthcare possible for their Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria 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.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria  Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
For Condition: Aplastic Anemia,Paroxysmal Hemoglobinuria, Nocturnal
Status: Recruiting
Sponsor(s): Johns Hopkins Oncology Center ,
Synopsis: OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia. II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients. III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.
Details: PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days. Patients are followed every 3 months for at least 2 years and annually thereafter.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria Not a candidate for allogeneic bone marrow transplantation Must meet one of the following criteria: - Severe aplastic anemia Less than 25% bone marrow cellularity and depression in two of three blood counts (reticulocytes less than 40,000/mm3, platelet count less than 20,000/mm3 and granulocytes less than 500/mm3) - Life-threatening paroxysmal nocturnal hemoglobinuria Absolute neutrophil count less than 500/mm3, platelet transfusion dependent, or thrombotic disease No Fanconi anemia No abnormal cytogenetics --Patient Characteristics-- Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 45% Other: Not preterminal or moribund Not pregnant
Total Enrollment: 25
Location and Contact Information:
Overall Study Official:
RobertBrodsky, Study Chair, Johns Hopkins Oncology Center
Johns Hopkins Oncology Center *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Richard Jones 410-955-2006
Additional Information:
Study ID Numbers: 199/13895; JHOC-96011702,JHOC-9611
Study Start Date: February 1996
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004464
Other Aplastic Anemia Studies:
1. Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Related Studies:
Other Aplastic Anemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Study of High Dose Cyclophosphamide in Patients with Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
|
|
|
|
|
|
|
|
