Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia

Blood Diseases Clinic654 enrolled

Overview

Thalidomide is known to have hypnosedative, immuno-modulatory and anti-angiogenic effects. The drug is widely used in several neoplastic disorders (e.g. multiple myeloma and malignant melanoma), inflammatory conditions (e.g. Crohn's disease) and skin disorders (e.g. leprosy). Thalidomide has been successfully used in adult thalassemia patients. The current study explores its role in transfusion-dependent thalassemia patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

654

Conditions

Thalassemia

Interventions

Thalidomide and HydroxyureaDRUG

Dosage: Thalidomide 1-4mg/kg/day, Hydroxyurea 10-20mg/kg/day

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: * Transfusion dependent thalassemia patients refractory to Hydroxyurea Exclusion Criteria: * Those with active systemic comorbidity, with past personal or family history of thrombophilia, recent fracture or recent major surgery

Locations (1)

Blood Diseases Clinic

Peshawar, Khyber Pakhtukhwa, Pakistan

Outcomes

Primary Outcomes

Haemoglobin Level

mg/dL

Time frame: 6-24 months

Response Rate (Excellent, Good, Partial and No response)

Time frame: 6-24 months

Adverse Effects

Time frame: 6-24 months

Data from ClinicalTrials.gov

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