Ruxolitinib With and Without CTLA-4 Ig Abatacept 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
NCT06008808
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib is provided by Incyte Corporation.
  • Abatacept — DRUG
    Abatacept is commercially available.

Study Details

Allogeneic hematopoietic cell transplantation (HCT) is one of the only curative intent therapies available for hematologic malignancies. HLA-matched sibling donors have historically offered the best clinical results but are unavailable for the majority of patients, while most patients do have readily available haploidentical donors. One of the risks of a haploidentical HCT is graft vs. host disease (GVHD), but it is difficult to reduce the incidence of GVHD without compromising the graft vs. leukemia (GVL) effect. The hypothesis of this study is that JAK inhibition with and without CTLA-4 Ig with haploidentical HCT may mitigate GVHD and cytokine release syndrome while retaining the GVL effect and improving engraftment.

Key Dates

Start date
May 7, 2024
Status verified
Apr 2026
Primary completion
Sep 8, 2027
Completion
Nov 27, 2027

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen 1: Ruxolitinib
    -Ruxolitinib at 5 mg twice per day (BID) beginning on Day -3 and continuing until Day 180 followed by a taper (duration of taper depends on dose of ruxolitinib at Day 180). Once a patient's counts have reached ANC ≥ 1.5 K/cumm, hemoglobin ≥ 9.0 g/dL, and platelets ≥ 50 K/cumm, ruxolitinib dosing will escalate to 10 mg BID.
  • Experimental: Regimen 2: Ruxolitinib + Abatacept
    * Ruxolitinib at 5 mg twice per day (BID) beginning on Day -3 and continuing until Day 180 followed by a taper (duration of taper depends on dose of ruxolitinib at Day 180). Once a patient's counts have reached ANC ≥ 1.5 K/cumm, hemoglobin ≥ 9.0 g/dL, and platelets ≥ 50 K/cumm, ruxolitinib dosing will escalate to 10 mg BID. * In addition, patients will receive abatacept 10 mg/kg IV over 30 minutes on days +5, +14, +28, and +56.

Primary Outcome Measure

Cumulative incidence of graft failure [ Time Frame: Day 35 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Ramzi Abboud, M.D.
[email protected]
314-454-8304
Ramzi Abboud, M.D. (PRINCIPAL_INVESTIGATOR)
Camille Abboud, M.D. (SUB_INVESTIGATOR)
Kelly Bolton, M.D. (SUB_INVESTIGATOR)
Amanda Cashen, M.D. (SUB_INVESTIGATOR)
Matt Christopher, M.D. (SUB_INVESTIGATOR)
Zachary Crees, M.D. (SUB_INVESTIGATOR)
John Dipersio, M.D., Ph.D. (SUB_INVESTIGATOR)
Todd Fehniger, M.D., Ph.D. (SUB_INVESTIGATOR)
Armin Ghobadi, M.D. (SUB_INVESTIGATOR)
Meagan Jacoby, M.D., Ph.D. (SUB_INVESTIGATOR)
Brad Kahl, M.D. (SUB_INVESTIGATOR)
Iskra Pusic, M.D. (SUB_INVESTIGATOR)
Mark Schroeder, M.D. (SUB_INVESTIGATOR)
Keith Stockerl-Goldstein, M.D. (SUB_INVESTIGATOR)
Geoffrey Uy, M.D. (SUB_INVESTIGATOR)
Ravi Vij, M.D. (SUB_INVESTIGATOR)
Matthew Walter, M.D. (SUB_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)

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Washington University School of Medicine· St Louis, MO

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