Status and phase
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About
The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or the combination of nivolumab with ipilimumab given after bone marrow transplant for patients with acute myelogenous leukemia and myelodysplastic syndrome.
Full description
The primary objectives of this study are:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Voluntary signed and dated IRB/IEC approved written informed consent form in accordance with regulatory and local guidelines.
Be 18 years or older and 70 years or younger on the day of signing consent
Have a confirmed diagnosis of non-M3 acute myeloid leukemia (AML) (Intermediate-II is high risk. Our population will consist of Intermediate-II and high risk patients or any FLT3+ AML) or IPSS intermediate -2 or high risk myelodysplastic syndrome (MDS) (Appendices A and B).
Have an available 6/6 related donor or an unrelated donor with a 10/10 match for HLA-A, B, C, DRB1 and DQ antigen who consents to provide a marrow or peripheral blood stem cell allograft. Typing is by DNA techniques: intermediate resolution for A, B and C, and high resolution for DRB1/DQ
Be receiving one of the following conditioning regimen: fludarabine at a dose of 30 mg/m2 IV daily for 5 days, busulfan at a dose of 130 mg/m2 IV daily for 2 days, and rabbit antithymocyte globulin (ATG) at a dose of 2 mg/kg IV daily for 2 days OR fludarabine at a dose of 30 mg/m2 IV daily for 4 days, melphalan at a dose of 140 mg/m2 for one day with or without ATG at a dose of 2 mg/kg IV daily for 2 days
Be deemed eligible for an allogenic stem cell transplantation as per institutional guidelines of the Blood and Marrow Transplantation Program at John Theurer Cancer Center at Hackensack University Medical Center
Patients with adequate organ function as measured by:
Have a performance status of 2 or lower on ECOG performance scale.
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
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Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects of childbearing potential should agree to ongoing pregnancy testing, to be performed prior to each dosing of ipilimumab and nivolumab. See Note below for definition of WOCBP.
Women must not be breastfeeding.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab, and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product, even if they have had a vasectomy. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception). See Note below for definition of WOCBP.
Females of childbearing potential must be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 2 years. See Note below for definition of WOCBP.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
8 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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