The Effective and Safety of Thalidomide in TI

Phase 2

• Conditions: Thalassemia
• Interventions: Drug: Thalidomide

• Registration Number: NCT03184844
• Lead Sponsor: Xiao-Lin Yin

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-02
• Status Verified: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-11
• Last Update Submitted: 2017-06-12
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Primary Completion: 2019-02-02
• Study Completion: 2019-05-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
thalidomide thalassemia	Thalidomide	thalidomide:50mg/d p.o

Primary Outcome Measures

Name	Time	Method
The Effective Rate of Patients	24 months	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.

Secondary Outcome Measures

Name	Time	Method
The Marked Improvement Rate of Patients	24 months	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.

Trial Locations

Locations (1)

NO.3 Hospital of the Chinese People's Liberation Army; 🇨🇳 Nanjing, Guangxi, China