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Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

ConditionPrimary Immune Thrombocytopenia (ITP)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

To evaluate whether orelabrutinib combined with romiplostim N01 can improve the quality of remission, increase the probability of successful drug withdrawal, and prolong the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who have received at least one line of prior therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in this study and provide written informed consent；

Age 18-80 years, inclusive, regardless of gender；

ECOG score 0 to 2；

Documented diagnosis of chronic primary Immune Thrombocytopenia (ITP) with a disease duration >12 months；

Disqualifiers

Subjects suffer from severe ITP at screening;

Subjects have other diseases which mention in protocol;

Subjects develop intracranial hemorrhage within 6 months prior to screening;

Active and uncontrollable infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • Orelabrutinib

    Drug

    Orelabrutinib will be given as 50mg per day orally, week 1-24

  • Romiplostim N01

    Drug

    Core Treatment Phase Recommended starting dose: 3 μg/kg subcutaneously once weekly. Monitor platelet count (PLT) and symptoms weekly for dose adjustment, max 10 μg/kg/week. Therapeutic target: Maintain PLT within the range of 50-200×10⁹/L. 1. PLT \< 50×10⁹/L: Increase by 1-3 μg/kg/week to max dose. Discontinue study if PLT remains \< 50×10⁹/L after 28d of max dose. 2. 50-200×10⁹/L: Maintain the minimum effective dose to reduce bleeding risk. 3. 200-400×10⁹/L: Decrease by 1-3 μg/kg/week. Discontinue if PLT ≥200×10⁹/L at 250 μg/week; resume when PLT \<50×10⁹/L (extend interval if needed). 4. PLT \>400×10⁹/L: Suspend; resume at 1-3 μg/kg lower dose when PLT \<200×10⁹/L (weekly monitoring). Tapering Phase For maintenance dose \>3 μg/kg/week: Taper by 1-3 μg/kg/week to ≤3 μg/kg (250 μg/week), then extend intervals (weekly→every 10 days→every 2 weeks). 1. PLT \<30×10⁹/L: Maintain current dose. 2. Two consecutive PLT \<30×10⁹/L: Discontinue study.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Orelabrutinib combined with Romiplostim N01Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

24-Week Sustained Platelet Response Rate

The proportion of subjects with a platelet count (PLT) ≥ 50×10⁹/L in at least 4 out of the last 6 visits during the 24-week treatment period, without rescue therapy administered in the previous 4 weeks

Time frame
Up to 24 weeks

Secondary outcomes

1

The sustained remission off-treatment (SROT)

At the end of follow-up (Week 56), the platelet count (PLT) is ≥ 30×10⁹/L and at least doubled compared to baseline, with no bleeding events and no rescue therapy administered during the period.

Time frame
Week 56
2

The cumulative number of weeks of platelet response

Up to Week 24, the cumulative number of weeks with a platelet count (PLT) ≥ 50×10⁹/L

Time frame
Up to 24 weeks
3

The time to first achievement of a platelet count ≥ 50×10⁹/L

The time to first achievement of a platelet count ≥ 50×10⁹/L

Time frame
Up to 24 weeks
4

Cumulative response time

Number of cumulative weeks with platelet counts ≥ 30 × 10⁹/L and doubling of the baseline count and without bleeding by Week 24

Time frame
Up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: