Treatment of Autoimmune Thrombocytopenia (AITP)
Completed · Phase 1
Conditions studied: Autoimmune Disease, Autoimmune Hemolytic Anemia, Thrombocytopenia
In brief
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.
Key facts
- Study ID
- NCT00001630
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 29
- Starts
- 1997-07-21
- Expected to finish
- 2009-06-11
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- ECOG performance status greater than 1.
- Cardiopulmonary disease including:
- History of coronary artery disease, angina pectoris or congestive heart failure.
- 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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