Acute Myeloid Leukemia Clinical Trial
Official title:
Epigenetic Modification for Relapse Prevention: a Dose-finding Study of Vorinostat Used in Combination With Low-dose Azacitidine in Children Undergoing Allogeneic Hematopoietic Cell Transplantation for Myeloid Malignancies
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | October 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 21 Years |
Eligibility | Inclusion Criteria: 1. Patient is 1 year to 21 years of age. 2. 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. 3. Patient has undergone allogeneic hematopoietic cell transplantation (no restrictions on conditioning regimen, donor or stem cell source, or GVHD prophylaxis regimen). 4. 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. 5. Female patient of childbearing potential has a negative screening pregnancy test (urine or serum, as per local institutional standard). 6. Female patient with infant(s) agrees not to breastfeed her infant(s) while on study. 7. Patient of child-bearing potential (male and female) agrees to use effective method of contraception during the study. Exclusion Criteria: 1. 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. 2. Patient has a planned administration of non-protocol chemotherapy, radiation therapy, donor leukocyte infusion, or immunotherapy during the planned study period. 3. Patient has a known allergy to azacitidine or vorinostat. 4. Patient has chronic myelogenous leukemia. 5. Concomitant use of coumarin-derived anticoagulants or valproic acid. - |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins All Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) | The primary outcome of this study is to determine the MTD of vorinostat in combination with low-dose azacitidine, using dose-escalation methodology. This is based on toxicities developed by participants enrolled on the study. | 4 months | |
Secondary | Dose-limiting toxicities | Rates of side effects from vorinostat will be recorded and described. | 4 months | |
Secondary | GVHD | Incidence of GVHD will be recorded and described. | 1 year | |
Secondary | Relapse | Incidence of relapse will be recorded and described | 1 year | |
Secondary | Survival | Duration of survival will be recorded and described | 1 year | |
Secondary | Immune recovery | Immune profile will be measured monthly for the first year post-transplant. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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