Itacitinib for the Prevention of Graft Versus Host Disease

Conditions

• Hematologic and Lymphocytic Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo stem cell transplant
• Busulfan — DRUG
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Fludarabine — DRUG
  Given IV
• Itacitinib — DRUG
  Given PO
• Tacrolimus — DRUG
  Given IV or PO
• Thiotepa — DRUG
  Given IV

Study Details

This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.

Key Dates

Start date

Jan 11, 2022

Status verified

Apr 2026

Primary completion

Apr 1, 2027

Completion

Apr 1, 2027

Study Design

Enrollment

31 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Supportive care (itacitinib)
  CONDITIONING: Patients receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, thiotepa IV on day -7, and fludarabine IV over 1 hour on days -6 to -3. STEM CELL TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4. Patients also receive itacitinib PO QD on days 5-60 in the absence of disease progression or unacceptable toxicity. Beginning day 5 after stem cell transplant, patients also receive tacrolimus IV over 24 hours until able to tolerate oral tacrolimus, whereby patients then receive tacrolimus PO BID.

Primary Outcome Measure

Incidence of acute grade 2-4 graft versus host disease (GVHD) [ Time Frame: At 100 days after stem cell transplant ]

Locations (1)

Find similar trials in Houston, TX

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