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Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

ConditionImmune Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

About this trial

The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed newly-diagnosed, treatment-naive ITP;

Platelet counts <30×10^9/L ;

Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

Willing and able to sign written informed consent.

Disqualifiers

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;

Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;

Current HIV infection or hepatitis B virus or hepatitis C virus infections;

Active infection;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zanubrutinib 80mg/d

    Drug

    Zanubrutinib: 80 mg taken orally once daily for 26 weeks

  • High dose dexamethasone

    Drug

    Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.

  • Zanubrutinib 160mg/d

    Drug

    Zanubrutinib: 160 mg taken orally once daily for 26 weeks

  • Zanubrutinib 240mg/d

    Drug

    Zanubrutinib: 240 mg taken orally once daily for 26 weeks

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Zanubrutinib 80mg/d + DexamethasoneExperimental treatment 2 interventions
Group B: Zanubrutinib 160mg/d + DexamethasoneExperimental treatment 2 interventions
Group C: Zanubrutinib 240mg/d + DexamethasoneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Sustained response

The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 26-week follow-up.

Time frame
26 weeks

Secondary outcomes

1

Initial Response (R)

Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.

Time frame
day 14
2

Initial complete response (CR)

Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.

Time frame
day 14
3

Time to response

The time from starting treatment to time of achievement of CR or R

Time frame
6 month
4

Duration of response (DOR)

Duration of response at 26-week follow up

Time frame
26 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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