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The Effective and Safety of Thalidomide in NTDT

Sponsor
Xiao-Lin Yin (Other)
Overall Status
Unknown status
CT.gov ID
NCT02995707
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
17.9
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.1530 patients will be enrolled, including type α 513 cases, type β 10~17 cases.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Phase II Clinical Trials of Thalidomide in NTDT
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: thalidomide thalassemia

thalidomide:50mg/d p.o

Drug: Thalidomide
thalidomide:50mg/d p.o at bedtime
Other Names:
  • fǎn yìng tíng

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The level of Hemoglobin [18 months]

      All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.

    Secondary Outcome Measures

    1. The effects of relative and absolute values of HbF [18 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NO.3 Hospital of the Chinese People's Liberation Army Nanjing Guangxi China 530021

    Sponsors and Collaborators

    • Xiao-Lin Yin

    Investigators

    • Study Director: Yin X Lin, director, NO.3 Hospital of the Chinese People's Liberation Army

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao-Lin Yin, Director, NO.3 Hospital of the People's Liberation Army, 303rd Hospital of the People's Liberation Army
    ClinicalTrials.gov Identifier:
    NCT02995707
    Other Study ID Numbers:
    • 303PLA
    First Posted:
    Dec 16, 2016
    Last Update Posted:
    Mar 22, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Xiao-Lin Yin, Director, NO.3 Hospital of the People's Liberation Army, 303rd Hospital of the People's Liberation Army
    Thalidomide NTDT
    Additional relevant MeSH terms:
    Thalassemia
    Thalidomide

    Study Results

    No Results Posted as of Mar 22, 2017