A Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing aGVHD After HLA-matched Transplantation

ConditionaGVHD
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in HLA haploidentical transplantation, the incidence of grade II-IV aGVHD after prevention, the incidence of primary graft failure, the rate of GVHD-free relapse-free survival (GRFS) (12 months), the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) (100 days - 1 year), treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety of the prevention regimen will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patients have been clearly diagnosed with hematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. The planned treatment for these patients is myeloablative or reduced-intensity conditioning, followed by HLA half-matched stem cell transplantation.

Has not received any systemic treatment, including extracorporeal photodynamic therapy (ECP)

KPS>60% or ECOG PS 0-2

Patients who have not received any other prophylactic immunosuppressive agents or aGVHD/cGVHD treatment are eligible

Disqualifiers

Pregnant women or women who are breastfeeding

Absolute Neutrophil Count (ANC) < 1.0 x 109/L or Platelet Count < 50 x 109/L

Uncontrolled active infections or active hepatitis B or hepatitis that requires antiviral treatment

Human Immunodeficiency Virus (HIV) positive

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivarmacitinib

    Drug

    Patients at the RP2D dose during the dose exploration phase were enrolled in the expansion study. Patients in the expansion study received RP2D Ivarmacitinib treatment daily for 3 days to 100 days.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: IvarmacitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

incidence of grade II-IV aGVHD

Time frame
up to 2 years

Secondary outcomes

1

the incidence of primary graft failure

Time frame
up to 2 years
2

the event-free survival (GRFS) without GVHD (12 months)

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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