The Effective and Safety of Thalidomide in TI

Xiao-Lin Yin

Status and phase

Unknown

Phase 2

Conditions

Thalassemia

Treatments

Drug: Thalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT03184844

303 PLA

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.