LOW DOSE THALIDOMIDE VERSUS HYDROXYUREA IN TRANSFUSION DEPENDENT THALASSEMIA PATIENTS

EFFICACY AND SAFETY OF LOW DOSE THALIDOMIDE VERSUS HYDROXYUREA IN TRANSFUSION DEPENDENT THALASSEMIA PATIENTS: A RANDOMIZED CONTROLLED TRIAL - THY

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025142

Enrollment

Registered

2020-05-13

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: D569- Thalassemia, unspecified

Interventions

Intervention1: 1: HYDROXYUREA 500 mg O.D orally for 6 months Intervention2: 2: THALIDOMIDE 50 mg O.D orally along with Tab Aspirin 75mg O.D orally for 6 months Control Intervention1: 3: STANDARD OF CA

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treatment naive adult transfusion dependent thalassemia patients of either sex willing to give written informed consent. 2. Age more than 18 years.

Exclusion criteria

Exclusion criteria: 1. Those with active systemic comorbidity, with past personal or family history of thrombophilia and recent splenectomy (within 3 months). 2. Absolute neutrophil count (ANC) less than 2000/ mm3 in the 8 weeks before study entry or a history of chronic neutropenia, defined as an ANC less than 2000/mm3. 3. Platelet count less than 100,000/mm3 or greater than 1,000,000/mm3 in the 8 weeks before study entry. 4. Evidence of liver disease, as defined by one or more of the following conditions: Alanine aminotransferase (ALT) level greater than three times the upper limit of normal in the 8 weeks before study entry. Serum albumin level less than 3 g/dL in the 8 weeks before study entry. 5. Creatinine level more than twice the upper limit of normal for age or greater than 1.5mg/dl. 6. Pregnant, planning to become pregnant, or breastfeeding. 7. HCV/HBV/HIV infection. 8. Currently being treated with any other experimental or fetal hemoglobin-modulating agent. 9. Current participation in any other studies of investigational drugs or devices. 10. Baseline peripheral neuropathy symptoms equivalent to grade 2 Therapy-induced peripheral neuropathy (TiPN) will be excluded.

Design outcomes

Primary

Measure	Time frame
1. Change in hemoglobin levelsTimepoint: at 3 months and 6 months	—

Secondary

Measure	Time frame
1. Average time to repeat transfusion over 6 months follow up. 2. Average volume of blood transfused over a period of 6 months compared to previous 6 months. 3. Percentage of patients with peak haemoglobin increase more than 2g/dl; 1-2 g/dl and less than 1g/dl. 4. Determinants of clinical (organomegaly and extramedullary hematopoiesis masses) and haematological correlates of response. 5. Incidence of severe adverse events or serious adverse events. Timepoint: 1. Average time to repeat transfusion over 6 months follow up. 2. Average volume of blood transfused over a period of 6 months compared to previous 6 months. 3. Percentage of patients with peak haemoglobin increase more than 2g/dl; 1-2 g/dl and less than 1g/dl. 4. Determinants of clinical (organomegaly and extramedullary hematopoiesis masses) and haematological correlates of response. 5. Incidence of severe adverse events or serious adverse events.	—

Measure

Time frame

1. Average time to repeat transfusion over 6 months follow up. 2. Average volume of blood transfused over a period of 6 months compared to previous 6 months. 3. Percentage of patients with peak haemoglobin increase more than 2g/dl; 1-2 g/dl and less than 1g/dl. 4. Determinants of clinical (organomegaly and extramedullary hematopoiesis masses) and haematological correlates of response. 5. Incidence of severe adverse events or serious adverse events. Timepoint: 1. Average time to repeat transfusion over 6 months follow up. 2. Average volume of blood transfused over a period of 6 months compared to previous 6 months. 3. Percentage of patients with peak haemoglobin increase more than 2g/dl; 1-2 g/dl and less than 1g/dl. 4. Determinants of clinical (organomegaly and extramedullary hematopoiesis masses) and haematological correlates of response. 5. Incidence of severe adverse events or serious adverse events.

—

Countries

India

Contacts

Public ContactURMIMALA BHATTACHARJEE

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH

alkakhadwal@hotmail.com7087008079

Outcome results

None listed

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