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Baricitinib for Post-HSCT Persistent Thrombocytopenia

ConditionsPersistent ThrombocytopeniaAllogeneic Hematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

About this trial

This is a prospective, open-label phase 1b/2 clinical trial to explore the safety and efficacy profiles of baricitinib in patients with thrombopoietin-receptor-agonist-refractory persistent thrombocytopenia after allogeneic hematopoietic stem cell transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-70 years;

Underwent allo-HSCT;

Meet the diagnostic criteria for delayed platelet engraftment (DPE) or secondary failure of platelet recovery (SFPR);

Have platelet counts consistently <20 ×10^9/L or transfusion-dependent within 14 days prior to enrollment;

Disqualifiers

Relapse of hematologic malignancy or MRD positivity;

Active infection;

Active graft-versus-host disease;

Thrombotic microangiopathy;

Trial design

Design model

Single group

Treatments tested in this trial

  • Baricitinib

    Drug

    Baricitinib, an orally administered, selective, reversible JAK1/2 inhibitor.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: BaricitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events in the Ib part

The incidence and severity of adverse events are assessed using the criteria of CTCAE 5.0.

Time frame
24 weeks
2

Overall response rate (ORR) for the IIa part

The proportion of patients achieving an overall response (OR), defined as a platelet count ≥20×10\^9/L maintained for more than 7 days without transfusion support. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.

Time frame
12 weeks

Secondary outcomes

1

Overall response rate (ORR) for the Ib part

The proportion of patients achieving an overall response (OR), defined as a platelet count ≥20×10\^9/L maintained for more than 7 days without transfusion support. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.

Time frame
12 weeks
2

Complete response (CR)

The proportion of patients achieving a complete response (CR), defined as a platelet count ≥50×10\^9/L maintained for more than 7 days without transfusion support. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.

Time frame
12 weeks
3

Durable response

The proportion of patients achieving a durable response (DR), defined as a platelet count ≥20×10\^9/L maintained for more than 8 weeks without transfusion. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.

Time frame
24 weeks
4

Time to response

The time from the date of the first dose of baricitinib to the date of OR or CR.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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