Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03755414
Phase
PHASE1
Status
Completed

Conditions

  • Acute Lymphocytic Leukemia
  • Acute Myelogenous Leukemia
  • Hodgkin Disease
  • Myelodysplastic Syndromes
  • Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stem cell transplantation — PROCEDURE
    Standard of care
  • Itacitinib — DRUG
    Itacitinib may be taken without regard to food.
  • Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) — OTHER
    * Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study) * Screening, day 14, day 28, day 42, day 74, day 100, day 180, taper period, and follow-up period (expansion study)
  • Human Activity Profile — OTHER
    * Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study) * Screening, day 14, day 28, day 42, day 60, day 74, day 100, day 180, taper period, and follow-up period (expansion study)

Study Details

In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.

Key Dates

Start date
Sep 4, 2019
Status verified
Mar 2025
Primary completion
Apr 26, 2024
Completion
May 26, 2024

Study Design

Enrollment
55 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pilot Study: Itacitinib
    * Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
  • Experimental: Expansion Phase: Itacitinib
    * Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
  • No Intervention: Donors
    -Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.

Primary Outcome Measure

Number of Participants With Graft Failure (Pilot Study Only) [ Time Frame: By day 35 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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