Back to resultsThe Effective and Safety of Thalidomide in NTDT
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 NTDT
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;
- 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 level of Hemoglobin
All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.
Secondary Outcome Measures
The effects of relative and absolute values of HbF
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
NCT02995707
Brief Title
The Effective and Safety of Thalidomide in NTDT
Official Title
The Phase II Clinical Trials of Thalidomide in NTDT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiao-Lin Yin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion.15~30 patients will be enrolled, including type α 5~13 cases, type β 10~17 cases.
Detailed Description
The project is a single arm research of thalidomide in NTDT,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 for 12 weeks. 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, 4-weeks visit, 8-weeks visit and 12-weeks visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia
Keywords
Thalidomide NTDT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (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 level of Hemoglobin
Description
All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The effects of relative and absolute values of HbF
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
18 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;
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
Three 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 NTDT
We'll reach out to this number within 24 hrs