ThalassemiaPhase 2NCT02995707
The Effective and Safety of Thalidomide in NTDT
A Phase 2 study testing Thalidomide in people with Thalassemia, run by Xiao-Lin Yin at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thalassemia
- What is being tested?
- Thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NO.3 Hospital of the Chinese People's Liberation Army
Nanjing, Guangxi, 530021
Li L zhu, Assistant, 0771 2870303, 530369641@qq.com
About this study
Official title: The Phase II Clinical Trials of Thalidomide in NTDT
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.
Read the 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.
- Conditions
- Thalassemia
- Being tested
- Thalidomide
- Keywords
- Thalidomide NTDT
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called fǎn yìng tíng
thalidomide:50mg/d p.o at bedtime
| Study group | Role | What they receive |
|---|---|---|
| thalidomide thalassemia | Experimental | thalidomide:50mg/d p.o Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of Hemoglobin
All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao-Lin Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao-Lin Yin, 303rd Hospital of the People's Liberation Army
- Investigators
- Yin X Lin, director, Study director, NO.3 Hospital of the Chinese People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995707
- Sponsor's protocol ID
- 303PLA
- Status last verified
- Mar 2017
- First submitted
- 8 Dec 2016
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Three months later after the last visit，summery report will be shared with other researchers through database.
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.
PubMed 29931453
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase II Clinical Trials of Thalidomide in NTDT
- ClinicalTrials.gov ID
- NCT02995707
- Acronym / sponsor ID
- 303PLA
- Conditions
- Thalassemia
- Keywords
- Thalidomide NTDT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiao-Lin YinUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thalidomide thalassemia | Experimental | Drug: Thalidomidethalidomide:50mg/d p.o |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThalidomideAlso: fǎn yìng tíngthalidomide:50mg/d p.o at bedtime | Drug | thalidomide thalassemia |
Primary outcome
The level of Hemoglobin
Time frame: 18 months
All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.
1 secondary outcome
The effects of relative and absolute values of HbF
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Derived from this study: PubMed 29931453Ren 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.
- Individual participant dataSharing planned: Yes. Three months later after the last visit，summery report will be shared with other researchers through database.
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Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
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Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
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β-Thalassemia Treatment With KL003 Cell Injection
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A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin X Lin, director study director
NO.3 Hospital of the Chinese People's Liberation Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Thalassemia, run by Xiao-Lin Yin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Ch xu, President (0771 2870303, 530369641@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of Hemoglobin (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.