Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation
United States15 participantsStarted 2019-05-01
Plain-language summary
The objective of this study is to evaluate the maximum tolerated (MTD) of vorinostat used in combination with low-dose azacitidine after allogeneic hematopoietic cell transplantation (alloHCT) for prevention of relapse of childhood myeloid malignancies.
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion criteria
✓. Patient is 1 year to 21 years of age.
✓. Patient has a diagnosis of AML, MDS, MDS/AML, MPAL, or JMML. Note: patients are allowed to have received a HMA or HDACi prior to undergoing alloHCT.
✓. Patient has undergone allogeneic hematopoietic cell transplantation (no restrictions on conditioning regimen, donor or stem cell source, or GVHD prophylaxis regimen).
✓. Patient and/or parent(s) or legal guardian(s) are capable of understanding the study, including potential benefits and risks, and sign written informed consent. Age-appropriate assent will be obtained.
✓. Female patient of childbearing potential has a negative screening pregnancy test (urine or serum, as per local institutional standard).
✓. Female patient with infant(s) agrees not to breastfeed her infant(s) while on study.
✓. Patient of child-bearing potential (male and female) agrees to use effective method of contraception during the study.
Exclusion criteria
✕. Patient is enrolled on a clinical trial with investigational post-transplant medications. Note: trials involving defibrotide, post-transplant cyclophosphamide, and Lactobacillus plantarum are permitted. Other trials involving investigational medications that aren't leukemia or GVHD-directed may also be permitted after consultation with the overall PI.
✕. Patient has a planned administration of non-protocol chemotherapy, radiation therapy, donor leukocyte infusion, or immunotherapy during the planned study period.