Back to resultsThe Effective and Safety of Thalidomide in TI
Primary Purpose
Thalassemia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Thalassemia focused on measuring Thalidomide TI
Eligibility Criteria
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.
Sites / Locations
- NO.3 Hospital of the Chinese People's Liberation ArmyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
thalidomide thalassemia
Arm Description
thalidomide:50mg/d p.o
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03184844
Brief Title
The Effective and Safety of Thalidomide in TI
Official Title
The Multi-center Clinical Trials of Thalidomide in TI
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
February 2, 2019 (Anticipated)
Study Completion Date
May 2, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiao-Lin Yin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia
Keywords
Thalidomide TI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thalidomide thalassemia
Arm Type
Experimental
Arm Description
thalidomide:50mg/d p.o
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
fǎn yìng tíng
Intervention Description
thalidomide:50mg/d p.o at bedtime
Primary Outcome Measure Information:
Title
The Effective Rate of Patients
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
The Marked Improvement Rate of Patients
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Ch xu, President
Phone
0771 2870303
Email
530369641@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin X Lin, director
Organizational Affiliation
NO.3 Hospital of the Chinese People's Liberation Army
Official's Role
Study Director
Facility Information:
Facility Name
NO.3 Hospital of the Chinese People's Liberation Army
City
Nanjing
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li L Zhu, Assistant
Phone
0771 2870303
Email
530369641@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Twenty four months later after the last visit，summery report will be shared with other researchers through database
Citations:
PubMed Identifier
29931453
Citation
Ren Q, Zhou YL, Wang L, Chen YS, Ma YN, Li PP, Yin XL. Clinical trial on the effects of thalidomide on hemoglobin synthesis in patients with moderate thalassemia intermedia. Ann Hematol. 2018 Oct;97(10):1933-1939. doi: 10.1007/s00277-018-3395-5. Epub 2018 Jun 22.
Results Reference
derived
Learn more about this trial
The Effective and Safety of Thalidomide in TI
We'll reach out to this number within 24 hrs