The Effective and Safety of Thalidomide in TI

• ClinicalTrials.gov Identifier: NCT03184844
• Recruitment Status: Unknown
• First Posted: June 14, 2017
• Last Update Posted: June 14, 2017
• Sponsor: Xiao-Lin Yin
• Information provided by (Responsible Party): Xiao-Lin Yin, 303rd Hospital of the People's Liberation Army

Tracking Information

• First Submitted Date: June 8, 2017
• First Posted Date: June 14, 2017
• Last Update Posted Date: June 14, 2017
• Actual Study Start Date: May 2, 2017
• Estimated Primary Completion Date: February 2, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 12, 2017)

The Effective Rate of Patients [ Time Frame: 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.

Original Primary Outcome Measures (submitted: June 11, 2017)

The level of Hemoglobin [ Time Frame: 24 months ]

All participants will complete the treatment for 24 months, the hemoglobin levels will be observed during the treatment.

Current Secondary Outcome Measures (submitted: June 12, 2017)

The Marked Improvement Rate of Patients [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: June 11, 2017)

The Safety of Thalidomide in TI [ Time Frame: 24 months ]

All participants will complete the treatment for 24 months, the adverse effects will be observed during the treatment.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effective and Safety of Thalidomide in TI
• Official Title: The Multi-center Clinical Trials of Thalidomide in TI
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Thalassemia

Intervention

Drug: Thalidomide

thalidomide:50mg/d p.o at bedtime

Other Name: fǎn yìng tíng

Study Arms

Experimental: thalidomide thalassemia

thalidomide:50mg/d p.o

Intervention: Drug: Thalidomide

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 11, 2017): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2, 2019
• Estimated Primary Completion Date: February 2, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03184844
• Other Study ID Numbers: 303 PLA
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Twenty four months later after the last visit，summery report will be shared with other researchers through database

• Current Responsible Party: Xiao-Lin Yin, 303rd Hospital of the People's Liberation Army
• Original Responsible Party: Same as current
• Current Study Sponsor: Xiao-Lin Yin
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: 303rd Hospital of the People's Liberation Army
• Verification Date: June 2017