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)

Phase II trial to study if the addition of fludarabine to the standard regimen of Anti-thymocyte globulin (ATG) and cyclosporine will improve remission rates in patients with severe and very severe aplastic anemia (SAA/VSAA)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/06/004676

Enrollment

Registered

2014-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- PATIENTS WITH APLASIC ANEMIA

Interventions

Intervention1: addition of fludarabine to the standard regimen of Anti-thymocyte globulin (ATG) and cyclosporine: Fludarabine at 30 mg/m2/day for 5 days (Day +1 to +5) along with the standard protocol

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. 12 months response rates and long term follow up.	—

Secondary

Measure	Time frame
1. To study the 12 month response rates and long term rates of relapse and incidence of clonal evolution 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. Timepoint: 12 MONHTS	—

Countries

India

Contacts

Public ContactDR BIJU GEORGE

CMC VELLORE

biju@cmcvellore.ac.in0416-2282352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026