The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
572
Tablet or intravenously (IV)
Intravenously (IV)
Tablet
Intravenously (IV)
Tablet or intravenously (IV)
Stanford Cancer Center
Palo Alto, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
GVHD-free survival (GFS)
GFS will be defined as the elapsed time between the date of transplant to Grade III-IV acute graft-versus host disease (GVHD), chronic GVHD requiring systemic immune suppression, or death by any cause.
Time frame: Up to 24 months post-transplant (Day 0)
GVHD/relapse or Progression-free Survival (GRFS)
Defined as Grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, underlying disease relapse or progression, or death by any cause.
Time frame: Up to 24 months post-transplant (Day 0)
Incidence of chronic GVHD
Defined by the protocol.
Time frame: Up to 24 months post-transplant (Day 0)
Incidence of acute grade 2-4 and 3-4 graft versus host disease (GVHD)
Defined by the protocol.
Time frame: Up to 24 months post-transplant (Day 0)
Time to neutrophil and platelet recovery
Defined by the Protocol.
Time frame: Up to 24 months post-transplant (Day 0)
Donor Cell Engraftment
Defined by the protocol.
Time frame: Up to 24 months post-transplant (Day 0)
Cumulative incidence of primary and secondary graft failure
Primary graft failure is defined as no neutrophil recovery to \> 500 cells/μL by Day 28 post HSCT. Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in absolute neutrophil counts \< 500 cells/μL, unresponsive to growth factor therapy, but cannot be explained by disease relapse or medications up to two years post-transplant.
Time frame: Day 28 and up to 2 years post-transplant (Day 0)
Disease Relapse or Progression
Defined by the protocol.
Time frame: Up to 24 months post-transplant (Day 0)
Non-relapse Mortality
Defined as death without evidence of disease progression or recurrence.
Time frame: Up to 24 months post-transplant (Day 0)
Toxicity and Infections
All Grade 2-5 toxicities according to CTCAE, version 5.0 will be tabulated for each intervention arm. The proportion of participants developing at least a Grade 2 or higher toxicity across intervention arms will be compared.
Time frame: Up to 24 months post-transplant (Day 0)
Disease-Free Survival
Defined as the time from date of transplant to death or relapse/progression, whichever comes first.
Time frame: Up to 24 months post-transplant (Day 0)
Overall Survival
Defined as the time interval between date of transplant and death from any cause.
Time frame: Up to 24 months post-transplant (Day 0)
Modified Lee Chronic GVHD Symptom Scale (mLSS)
The modified Lee chronic GVHD symptom scale (mLSS) is a 28 item measure with seven domains referent to the past seven days: skin, mouth, eye, lung, psychoemotional, vitality and nutrition.
Time frame: Up to 24 months post-transplant (Day 0)
Individual Symptom Scale: Modified Medical Research Council (mMRC) Dyspnea scale
mMRC dyspnea scale assesses the degree of functional disability due to dyspnea.
Time frame: Up to 24 months post-transplant (Day 0)
Individual Symptom Scale: Two items from a protocol defined survey
Two items from a protocol defined survey are used to measure hemorrhagic cystitis symptom burden.
Time frame: Up to 24 months post-transplant (Day 0)
Individual Symptom Scale: Oral Health Impact Profile (OHIP)
OHIP measures dysfunction, discomfort and disability caused by oral conditions.
Time frame: Up to 24 months post-transplant (Day 0)
Individual Symptom Scale: Ocular Surface Disease Index (OSDI)
OSDI measures symptoms and vision effects of dry eye disease.
Time frame: Up to 24 months post-transplant (Day 0)
Work Productivity and Impairment Questionnaire (WPAI)
WPAI measures the impact on ability to work and perform regular activities.
Time frame: Up to 24 months post-transplant (Day 0)
Comprehensive Score for Financial Toxicity (COST)
COST measures the impacts of treatment on finances and economic status of the patient households.
Time frame: Up to 24 months post-transplant (Day 0)
Patient-Reported Economic, Income and Insurance Data (PREIID)
PREIID measures the impacts of treatment on finances and economic status of the patient households.
Time frame: Up to 24 months post-transplant (Day 0)
Patient Reported Caregiver Assessment (PRCA)
PRCA measures the type of support provided by caregivers, and the economic burden to patient caregivers.
Time frame: Up to 24 months post-transplant (Day 0)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
RECRUITINGIndiana University Cancer Center
Indianapolis, Indiana, United States
RECRUITINGUniversity of Kansas Hospital Authority
Kansas City, Kansas, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITING...and 20 more locations