Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04339101
Phase
PHASE2
Status
Completed

Conditions

  • Acute Leukemia
  • Hematologic and Lymphocytic Disorder
  • Myelodysplastic Syndrome
  • Primary Myelofibrosis
  • Secondary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Given via infusion
  • Itacitinib Adipate — DRUG
    Given PO
  • Melphalan — DRUG
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Sirolimus — DRUG
    Given PO
  • Tacrolimus — DRUG
    Given IV or PO

Study Details

This phase IIa trial studies the side effects of itacitinib when given together with standard treatment (tacrolimus and sirolimus), and to see how well it works in preventing graft-versus-host-disease (GVHD) in patients with acute leukemia, myelodysplastic syndrome or myelofibrosis who are undergoing reduced intensity conditioning donor stem cell transplantation. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Adding itacitinib to tacrolimus and sirolimus may reduce the risk GVHD and ultimately improve overall outcome and survival after donor stem cell transplantation.

Key Dates

Start date
Nov 11, 2020
Status verified
Mar 2026
Primary completion
May 22, 2023
Completion
Oct 9, 2025

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (itacitinib adipate, tacrolimus, sirolimus)
    RIC: Patients receive fludarabine via infusion on days -9 to -5 and melphalan on day -4 in the absence of disease progression or unacceptable toxicity. ALLOGENEIC HSCT: Patients undergo HSCT on day 0. GVHD PROPHYLAXIS: Patients receive itacitinib PO QD beginning on day -3 and continuing until day 100 in the absence of disease progression or unacceptable toxicity. Patients also receive tacrolimus IV or PO and sirolimus PO beginning day -3 and continuing until day 100 with a taper in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Graft-versus-host Disease Free Relapse Free (GRFS) at 1 Year [ Time Frame: From the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first, assessed at 1 year post transplant. ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CA

Related Studies