Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation
NCT ID: NCT04127721
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2020-09-22
2020-09-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To estimate the graft-versus (vs.) host disease-free/relapse free survival (GRFS) rate of itacitinib used as prophylaxis to prevent graft versus host disease (GVHD) after allogeneic stem cell transplantation (ASCT) at one year.
SECONDARY OBJECTIVES:
I. To assess the time to neutrophil and platelet engraftment and compare between matched and unmatched donors.
II. To assess safety of itacitinib as measured by non-relapse mortality (NRM) at day 100.
III. To assess the toxicity profile associated with this regimen. IV. To assess the incidence of acute and chronic GVHD. V. To assess the incidence of disease relapse. VI. To assess the incidence of non-relapse mortality. VII. To assess overall survival and progression-free survival. VIII. To assess the incidence of withdrawal syndrome in patients with myelofibrosis.
TERTIARY OBJECTIVES (CORRELATIVE STUDIES):
I. To study immune recovery and cytokines at various time points pre and post-transplant.
II. To study deoxyribonucleic acid (DNA) damage studies in various cells post-transplant.
OUTLINE:
CONDITIONING CHEMOTHERAPY: Patients receive busulfan intravenously (IV) over 3 hours on days -20, -13, and -6 to -3, and fludarabine IV over 1 hour on days -6 to -3 in the absence of disease progression or unacceptable toxicity.
ALLOGENEIC STEM CELL TRANSPLANTATION: Patients undergo ASCT on day 0.
GVHD PROPHYLAXIS: Patients receive itacitinib orally (PO) once daily (QD) on days -21 to 80. Patients with no evidence of GVHD at day 80 receive a tapered dose of itacitinib until day 90. Patients also receive tacrolimus IV then PO twice daily (BID) for 3 months when able, and methotrexate IV over 30 minutes on days 1, 3, and 6 (day 11 also for patients with a matched unrelated donor).
After completion of study treatment, patients are followed up at 100 days, 6 months, and 1 year.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prevention (itacitinib, busulfan, fludarabine, ASCT)
CONDITIONING CHEMOTHERAPY: Patients receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, and fludarabine IV over 1 hour on days -6 to -3 in the absence of disease progression or unacceptable toxicity.
ALLOGENEIC STEM CELL TRANSPLANTATION: Patients undergo ASCT on day 0.
GVHD PROPHYLAXIS: Patients receive itacitinib PO QD on days -21 to 80. Patients with no evidence of GVHD at day 80 receive a tapered dose of itacitinib until day 90. Patients also receive tacrolimus IV then PO BID for 3 months when able, and methotrexate IV over 30 minutes on days 1, 3, and 6 (day 11 also for patients with a matched unrelated donor).
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo ASCT
Busulfan
Given IV
Fludarabine
Given IV
Itacitinib
Given PO
Methotrexate
Given IV
Tacrolimus
Given IV and PO
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo ASCT
Busulfan
Given IV
Fludarabine
Given IV
Itacitinib
Given PO
Methotrexate
Given IV
Tacrolimus
Given IV and PO
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with hematological disorders undergoing ASCT with conditioning regimen of timed sequential busulfan and fludarabine
* Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated donor available
* Life expectancy of at least 12 weeks (3 months)
* Direct bilirubin not greater than 1 mg/dL
* Alanine transaminase (ALT) less than or equal 3 x upper limit of normal range
* Serum creatinine less than 1.5 x the upper limit of normal range and creatinine clearance greater than 50 ml/min
* Diffusing capacity for carbon monoxide (DLCO) 65% of predicted corrected for hemoglobin
* Left ventricle ejection fraction (LVEF) of at least 50%
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
* Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent until at least 30 days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Exclusion Criteria
* Active or clinically significant cardiac disease including:
* Congestive heart failure New York Heart Association (NYHA) \> class II
* Active coronary artery disease
* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before transplant, or myocardial infarction within 6 months before transplant
* Patients with uncontrolled infections
* Patients with active hepatitis B and C
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Uday R Popat
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M D Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2019-05753
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0505
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0505
Identifier Type: -
Identifier Source: org_study_id