The Effective and Safety of Thalidomide in TI

Thalassemia Clinical Trial

Official title:

The Multi-center Clinical Trials of Thalidomide in TI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03184844
• Other study ID #: 303 PLA
• Status: Recruiting
• Phase: Phase 2
• First received: June 8, 2017
• Last updated: June 12, 2017
• Start date: May 2, 2017
• Est. completion date: May 2, 2019

Study information

• Verified date: June 2017
• Source: 303rd Hospital of the People's Liberation Army
• Contact: Liu Ch xu, President
• Phone: 0771 2870303
• Email: 530369641[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of TI to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion,60~100 patients will be enrolled.

Description:

The project is a single arm research of thalidomide in TI,patients volunteered to participate in this trial and met the following inclusion criteria will be enrolled: age from 18~65, Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Subjects should take thalidomide 50mg per day. During this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions were closely observed. According to the protocol, the blood routine, peripheral blood reticulocyte count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were evaluated in screening-period visit,1-month visit, 3-months visit , 6-months visit ,9-months visit, 12-months visit and 15-months visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2, 2019
• Est. primary completion date: February 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients meeting all of the following criteria will be considered for admission to the trial:

• Diagnosis of NTDT;

• Ages 18-65 years;

• ECOG: 0~2 scores;

• If not blood transfusion,the level of HB<90g/dl, or blood transfusion to maintain the HB;

• Sign an informed consent agreeing to the clinical trial participation.

Exclusion Criteria:

• Patients presenting with any of the following criteria will not be included in the trial:

• Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;

• Women during Pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures;

• Patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases;

• Patients Allergic to the drug ingredients;

• Patients with any Mental problem;

• Patients had Participated in other drug clinical trials in the past 1 month;

• Patients had a history of venous or arterial thrombosis;

• In certain circumstances that the researchers determined it was not suitable for the research.

Related Conditions & MeSH terms

• Thalassemia

Intervention

Drug:
• Thalidomide
thalidomide:50mg/d p.o at bedtime

Locations

Country	Name	City	State
China	NO.3 Hospital of the Chinese People's Liberation Army	Nanjing	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Xiao-Lin Yin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effective Rate of Patients	All participants will complete the treatment for 24 months, the hemoglobin value will be observed during the treatment,the value increased more than 20g/L defined as the marked effect,increased to 10~20g/L defined as effective, otherwise invalid.	24 months
Secondary	The Marked Improvement Rate of Patients	The highest hemoglobin value will be observed,the value increased more than 20g/L defined as the marked effect,increased to 10~20g/L defined as effective, otherwise invalid.	24 months