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Treatment of Aplastic Anemia

Compassionate use of Arsenic trioxide in patients with Aplastic Anemia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003480
Enrollment
20
Registered
2013-03-14
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- Refractory Severe Aplastic Anemia

Interventions

Intervention1: Injection Arsenic Trioxide: 0.15 mg/kg/day, 5-days a week upto 8-weeks Intervention2: Injection Arsenic trioxide: 0.15 mg/kg/day, OD, 5-days a week upto 8-weeks one hour infusion on out

Sponsors

Principal Investigator Research Fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Acquired aplastic anaemia 2. Age above 18 years 3. Patient / Legally Acceptable Representative able to provide informed consent 4. Hypocellular bone marrow- 5. With any severity of disease as defined below: A. Not Severe Aplastic Anaemia i. Hb ii. ANC iii. PL B. Severe Aplastic Anaemia i. Neutrophil count 0.5 x 109/l ii. Platelets iii. Reticulocytes C. Very Severe Aplastic Anaemia i. If the ANC is 6. Prior treatment with any of the standard treatment Equine/rabbit Antithymocyte Globulin (ATG) and or cyclosporine or other drugs danazol, mycophenolate, prednisolone etc.

Exclusion criteria

Exclusion criteria: History of cancer, renal failure, HIV positive status, Clonal disorders, pregnancy, participation in another investigational study 30-days before the current study

Design outcomes

Primary

MeasureTime frame
Recovery of Aplastic anemiaTimepoint: At 6 months—

Secondary

MeasureTime frame
Time to relapse and mortalityTimepoint: 180 days—

Countries

India

Contacts

Public ContactDr Pankaj Malhotra

PGIMER

malhotrapankaj@hotmail.com2756680

Outcome results

None listed

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