Thrombocytopenia Clinical Trial
Official title:
High-Dose Cyclophosphamide With CD34+ Selected Autologous Hematopoietic Cell Support for Treatment of Refractory Chronic Autoimmune Thrombocytopenia
Verified date | March 21, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Platelets are particles found along with red and white blood cells in the blood that play a
role in the process of blood clotting. Disorders affecting the platelets can lower the amount
of platelets in the blood and put patients at risk of bleeding. The condition of low
platelets is referred to as thrombocytopenia.
Thrombocytopenia can be associated with a variety of diseases including cancer, leukemia,
tuberculosis, or as a result of an autoimmune reaction. Autoimmune reactions are disorders in
which the normal immune system begins attacking itself. Autoimmune thrombocytopenia (AITP) is
a disorder of low blood platelet counts in which platelets are destroyed by antibodies
produced by the immune system.
Unfortunately, many patients with AITP do not respond to standard treatments for
thrombocytopenia. Cyclophosphamide is a drug that works to suppress the activity of the
immune system. Researchers believe that combining this drug with transplanted rescued blood
stem cells may provide effective treatment for AITP.
The purpose of this study is to explore the affordability and safety of this therapy for the
treatment of AITP. The effectiveness of the therapy will be measured by the number of
patients whose platelet levels rise greater than 100,000/m3.
If this treatment approach appears affordable, this study will form the basis for a larger
study to compare alternate treatment approaches.
Status | Completed |
Enrollment | 29 |
Est. completion date | June 11, 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
- INCLUSION CRITERIA: Male or female, ages 18-65 years old. Refractory severe chronic autoimmune thrombocytopenia, with or without autoimmune hemolytic anemia (Evan's syndrome), with all the following: 1. Platelet count frequently below 20,000/mm(3) despite active treatment for a period of greater than 6 months. 2. Normal or increased megakaryocytes on bone marrow aspirate/bx. 3. No plausible alternative etiology such as drug-mediated thrombocytopenia, marrow failure syndrome or thrombocytopenia related to viral or bacterial infection. 4. Failure of treatment with: i. conventional-dose steroids (e.g., prednisone or dosage of 40 mg/day or equivalent, followed by dosage taper) for at least 3 months. ii. intravenous immunoglobulin. iii. splenectomy. e. Episodic bleeding requiring transfusions or ecchymoses interfering with ordinary daily activities. EXCLUSION CRITERIA: ECOG performance status greater than 1. Cardiopulmonary disease including: 1. History of coronary artery disease, angina pectoris or congestive heart failure. 2. LV ejection fraction less than 40 percent by 2D echocardiogram. Renal disease, serum creatinine greater than 2.5 mg/dL or creatinine clearance less than 30 mL/min. Significant hepatic dysfunction, bilirubin greater than 2 mg/dL or transaminases greater than 2 times UNL. Uncorrected coagulopathy. Bone marrow aplasia (cellularity less than 10 percent), single or multilineage hematopoietic failure, myelodysplastic syndrome, or extensive marrow fibrosis. History or active diagnosis of malignancy (except treated non-melanoma skin cancer or cevical carcinoma in situ). HIV positive. Pregnancy or lactation, unwillingness to practice adequate birth control in the peritransplant period. Psychiatric illness or mental incapacity to understand and give informed consent. Other medical illness or condition which, in the opinion of the Investigators, may contraindicate participation in this study due to patients' risk or compromise of study integrity. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
George JN, el-Harake MA, Raskob GE. Chronic idiopathic thrombocytopenic purpura. N Engl J Med. 1994 Nov 3;331(18):1207-11. Review. — View Citation
Karpatkin S. Autoimmune (idiopathic) thrombocytopenic purpura. Lancet. 1997 May 24;349(9064):1531-6. Review. — View Citation
Semple JW, Freedman J. Abnormal cellular immune mechanisms associated with autoimmune thrombocytopenia. Transfus Med Rev. 1995 Oct;9(4):327-38. Review. — View Citation
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