Study of addition of fludarabine to the standard regimen of Anti-thymocyte globulin (ATG) and cyclosporine in patients with aplastic anemia (condition that occurs when the body stops producing enough new blood cells)
- Conditions
- Health Condition 1: null- PATIENTS WITH APLASIC ANEMIA
- Registration Number
- CTRI/2014/06/004676
- Lead Sponsor
- INVESTIGATOR INITIATED STUDY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 20
Adult patients with SAA or VSAA who give consent for the trial [Definition of SAA is as per Camitta et al â?? Bone marrow cellularity < 25% with 2 out of the following 3 criteria â?? Neutrophils < 0.5 x 109/L, Platelet count < 20 x 109/L, reticulocyte count < 20 x 109/L]; VSAA defined as Neutrophils < 0.2 x 109/L with all other criteria of SAA
1. Children 15 years of age
2. Patients with any abnormalities suggestive of congenital bone marrow failure syndromes such as Fanconiâ??s anemia or Dyskeratosis congenita
3. Patients who had active infection requiring admission within 2 weeks prior to ATG
4. Pregnancy
5. Creatinine 1.4 mg/dl
6. Prior history of treatment with ATG
7. Seropositivity for HIV, Hepatitis B or C
8. Any other significant co-morbidities that make death likely in the next 4 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess if the addition of fludarabine to the standard protocol of Anti-thymocyte globulin (ATG) and cyclosporine can improve the 6 month remission rates in patients with severe aplastic anemia (SAA) and very severe aplastic anemia (VSAA)Timepoint: Incidence of infection in first 3 months. <br/ ><br>12 months response rates and long term follow up.
- Secondary Outcome Measures
Name Time Method 1. To study the 12 month response rates and long term rates of relapse and incidence of clonal evolution <br/ ><br>2. To study whether there is a difference in the incidence of infection in the first 3 months of treatment compared with a historical cohort of age matched patients treated with ATG and cyclosporine. <br/ ><br>Timepoint: 12 MONHTS