Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia (Thal-Thalido)

March 10, 2022 updated by: Muhammad Tariq Masood Khan, Blood Diseases Clinic

Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia Patients of Pakistan

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

654

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtukhwa
      • Peshawar, Khyber Pakhtukhwa, Pakistan, 0000
        • Blood Diseases Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thalidomide in combination with hydroxyurea
All the study patients refractory to hydroxyurea will be given thalidomide at an average dose of 2mg/kg/day (range 1-4mg/kg/day). Participants will also be continued on hydroxyurea at a dose of 10-20 mg/kg/day.
Drug: Thalidomide and Hydroxyurea
Dosage: Thalidomide 1-4mg/kg/day, Hydroxyurea 10-20mg/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemoglobin Level
Time Frame: 6-24 months
mg/dL
6-24 months
Response Rate (Excellent, Good, Partial and No response)
Time Frame: 6-24 months
6-24 months
Adverse Effects
Time Frame: 6-24 months
6-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blood Diseases Clinic

Collaborators

University of Peshawar

Investigators

  • Principal Investigator: Muhammad Tariq M Khan, MBBS, PhD, Blood Diseases Clinic
  • Study Director: Zahid Ali, PharmD, MPhil, Department of Pharmacy, University of Peshawar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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