Status:
COMPLETED
Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation
Lead Sponsor:
Washington University School of Medicine
Conditions:
Graft-versus-host-disease
Graft Vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
In this trial, the investigators will begin to explore the possibility that, as in mice, JAK1/2 inhibition with hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) w...
Eligibility Criteria
Inclusion
- Patients must meet the following criteria within 30 days prior to Day 0 unless otherwise noted.
- Diagnosis of a hematological malignancy listed below:
- Acute myelogenous leukemia (AML) in complete morphological remission (based on IWG Criteria).
- Acute lymphocytic leukemia (ALL) in complete morphological remission (MRD negative, based on IWG Criteria).
- Myelodysplastic syndrome with less than 10% blasts in bone marrow.
- Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete or partial remission.
- Planned treatment is myeloablative or reduced intensity conditioning followed by peripheral blood HLA matched donor transplantation
- Available HLA-identical donor who meets the following criteria:
- At least 18 years of age.
- HLA-identical donor/recipient match by high-resolution typing per institutional standards.
- In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting HSC.
- No active hepatitis.
- Negative for HTLV and HIV.
- Not pregnant.
- Donor selection will be in compliance with institutional standards
- Safety Lead-In Phase: For the first three patients at each dose level, related donors must consent to a second product collection should it prove necessary.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate organ function as defined below:
- Total bilirubin must be within normal range at baseline.
- AST (SGOT) and ALT (SGPT) ≤ 3.0 x IULN.
- Estimated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault Formula.
- Oxygen saturation ≥ 90% on room air.
- LVEF ≥ 40%.
- FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted. If DLCO is \< 40%, patients will still be considered eligible if deemed safe after a pulmonary evaluation.
- At least 18 years of age at the time of study registration
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Must be able to receive GVHD prophylaxis with tacrolimus, mini-methotrexate with or without ATG or post transplant Cy with MMF and tacrolimus as outlined in the protocol
Exclusion
- Must not have undergone a prior allogeneic donor (related, unrelated, or cord) transplant. Prior autologous transplant is not exclusionary.
- Known HIV or active hepatitis B or C infection.
- Known latent tuberculosis infection, or at high risk for latent TB infection, or a positive t-spot tuberculosis test
- Known hypersensitivity to one or more of the study agents, including baricitinib.
- Must not have myelofibrosis or other disease known to prolong neutrophil engraftment to \> 35 days after transplant.
- Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (Day -3).
- Pregnant and/or breastfeeding.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
- Immunosuppressive doses of steroids. Subjects with steroids for adrenal insufficiency will not be excluded.
- History of unprovoked thrombosis or known thrombophilia. Provoked and/or superficial DVTs are eligible provided they are treated and resolved at the time of screening.
- Recent (less than 1 year from screening) myocardial infarction or embolic stroke
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04131738
Start Date
April 7 2020
End Date
August 17 2022
Last Update
May 10 2023
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110