Hematologic Malignancies
Conditions
Keywords
graft-versus-host disease (GVHD), allogeneic hematopoietic stem cell transplant (allo-HCT)
Brief summary
The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
Interventions
DRUGCyclophosphamide
An intermediate dose (medium dose) of Post-transplant Cyclophosphamide
DRUGMycophenolate Mofetil
Day +5 to +35
DRUGRuxolitinib
twice a day
DRUGTacrolimus
Day +5, taper per SoC
Sponsors
Memorial Sloan Kettering Cancer Center
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18- years-old at time of consent * Diagnosis: hematologic malignancy in morphologic remission (blasts \<5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response * Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical * Karnofsky score ≥ 70% * Female subjects of childbearing potential (\<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months. °Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: \*Intrauterine device (IUD) plus one barrier method \*Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method \*2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \* A vasectomized partner. * For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
Exclusion criteria
* Recipient of CD34+ selected or engineered stem cell graft * Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin) * Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance. * Severely impaired renal function defined by serum creatinine \> 2mg/dL, renal dialysis requirement. * Use of investigational agent within 14 days pre-HCT * Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months * Uncontrolled psychiatric illness * Female patient who is pregnant or breastfeeding * Known allergy or sensitivity to ruxolitinib
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess cGVHD-free survival | 1 year post-HCT | Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of grade 2-4 infections. | 1 year | Grade 2-4 infections by CTCAE v5 either clinically or microbiologically will be assessed throughout the study until day +365. Causality and relationship with ruxolitinib will be determined. |
Countries
United States
Contacts
CONTACTDoris Ponce, MD, MS
CONTACTBrian Shaffer, MD
PRINCIPAL_INVESTIGATORDoris Ponce, MD, MS
Memorial Sloan Kettering Cancer Center
Outcome results
None listed