Status:
ACTIVE_NOT_RECRUITING
Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation
Lead Sponsor:
Johns Hopkins All Children's Hospital
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief 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 pre...
Detailed Description
Children and adolescents ages 1 to 21 years of age who are undergoing allogeneic hematopoietic cell transplantation for a myeloid malignancy (AML, MDS, JMML, MPAL) will be eligible. There are no restr...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patient has a known allergy to azacitidine or vorinostat.
- Patient has chronic myelogenous leukemia.
- Concomitant use of coumarin-derived anticoagulants or valproic acid.
- \-
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03843528
Start Date
May 1 2019
End Date
October 30 2026
Last Update
August 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701