The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)

NCT ID: NCT07065968

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-19
• Study Completion Date: 2027-12-30

Brief Summary

A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).

Detailed Description

The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

Immune Thrombocytopenia (ITP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teriflunomide plus Dexamethasone

Oral Teriflunomide was given at a dose of 14 mg once daily for 24 weeks, and dexamethasone was given at a dose of 40mg orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.

Group Type: EXPERIMENTAL

Teriflunomide

Intervention Type: DRUG

Teriflunomide 14 mg orally once daily for 24 weeks.

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg orally once daily for four consecutive days.

Dexamethasone

Dexamethasone was given at a dose of 40mg, orally once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg orally once daily for four consecutive days.

Interventions

Teriflunomide

Teriflunomide 14 mg orally once daily for 24 weeks.

Intervention Type: DRUG

Dexamethasone

Dexamethasone 40 mg orally once daily for four consecutive days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients aged ≥18 years;

2. Newly diagnosed, treatment naïve ITP patients;

3. Patients with a platelet count <30 x10^9/L or a platelet count <50 x10^9/L with bleeding manifestations at the enrollment;

4. Willing and able to sign written informed consent.

Exclusion Criteria

1. Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);

2. Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN);

3. Severe cardiac, renal, hepatic, or respiratory insufficiency;

4. Severe immunodeficiency;

5. Pregnancy or lactation;

6. Active or a history of malignancy;

7. Active infection requiring systemic therapy;

8. Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;

9. A known diagnosis of other autoimmune diseases;

10. Patients who are deemed unsuitable for the study by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Health Science Center

OTHER

Sponsor Role: collaborator

Cisen Pharmaceutical CO., LTD.

INDUSTRY

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice president of Peking Univeristy Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao-Hui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Institute of Hematology, Peking University People's Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao-Hui Zhang, MD

Role: CONTACT

zhangxh@bjmu.edu.cn

+8613522338836

Li-Ping Yang, MD

Role: CONTACT

lpyang@bjmu.edu.cn

+8618519172033

Facility Contacts

Yu-Jun Dong, MD

Role: primary

dongy@hsc.pku.edu.cn

+8618210264969

Xiao-Hui Zhang, MD

Role: primary

zhangxh@bjmu.edu.cn

+8613522338836

Li-Ping Yang, MD

Role: backup

lpyang@bjmu.edu.cn

+8618519172033

Hong-Mei Jing, MD

Role: primary

hongmeijing@bjmu.edu.cn

+8615611908428

Other Identifiers

TY2025006

Identifier Type: -

Identifier Source: org_study_id