GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

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Incyte

Status and phase

Terminated
Phase 1

Conditions

Hematologic Malignancies

Treatments

Drug: Calcineurin inhibitor
Drug: Itacitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03320642
INCB 39110-119/GRAVITAS-119

Details and patient eligibility

About

The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and < 5% blasts in the bone marrow.
  • Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.
  • Must be candidates for reduced-intensity conditioning regimens.
  • Must be candidates for peripheral blood stem cell transplants.
  • Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2.
  • Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation.
  • Be willing to avoid pregnancy or fathering children.

Exclusion criteria

  • Has previously received an allogenic hematopoietic stem cell transplant.
  • Presence of an active uncontrolled infection.
  • Known HIV infection.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
  • Prior malignancies.
  • Severe organ dysfunction.
  • Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
  • Currently breastfeeding.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications.
  • Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study.
  • History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to > 28 days after transplant.
  • Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

84 participants in 1 patient group

Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions
Experimental group
Description:
Itacitinib in combination with a CNI-based intervention.
Treatment:
Drug: Itacitinib
Drug: Calcineurin inhibitor

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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