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

Phase 2RecruitingNCT07065968

Peking University People's Hospital132 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Immune Thrombocytopenia (ITP)

Interventions

TeriflunomideDRUG

Teriflunomide 14 mg orally once daily for 24 weeks.

DexamethasoneDRUG

Dexamethasone 40 mg orally once daily for four consecutive days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

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

Beijing, Beijing Municipality, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Sustained response

Sustained response was defined as a platelet count ≥ 30 x10\^9/L and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least three of the four visits of the last 8 weeks of treatment.

Time frame: Week 24

Secondary Outcomes

Initial response

The number of participants with achievement of CR or R at 4 weeks. Complete response (CR) was defined as a platelet count ≥ 100 x10\^9/L and absence of bleeding. Response (R) was defined as a platelet count ≥ 30 x10\^9/L and at least a 2-fold increase of the baseline count and absence of bleeding. No response was defined as a platelet count of less than 30 x10\^9/L, or less than two times increase from baseline platelet count, or bleeding.

Time frame: Week 4

Time to response

The time from treatment initiation to time of achievement of CR or R.

Time frame: Week 24

Duration of response

The time from the achievement of a CR or R to the loss of CR or R.

Time frame: Week 24

Bleeding events

Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale.

Time frame: Week 24

Adverse events

Adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Time frame: Week 24

Health-related quality of life (HRQoL)

ITP-patient assessment questionnaire (ITP-PAQ) was used to assess the HRQoL before and after treatment.

Central Contacts

Xiao-Hui Zhang, MD

CONTACT

+8613522338836 zhangxh@bjmu.edu.cn

Li-Ping Yang, MD

CONTACT

+8618519172033 lpyang@bjmu.edu.cn

Data from ClinicalTrials.gov

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