Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation

Launched by JOHNS HOPKINS ALL CHILDREN'S HOSPITAL · Feb 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called vorinostat, which is being tested in combination with another drug, low-dose azacitidine, to see how well it can prevent the return of certain blood cancers (like acute myeloid leukemia) in children and young adults who have received a stem cell transplant. The main goal is to find the highest dose of vorinostat that can be safely given without causing serious side effects.

To be eligible for this trial, participants must be between 1 and 21 years old and have been diagnosed with specific types of blood cancers. They should have already undergone a stem cell transplant and be able to understand the study's purpose and agree to participate. While taking part in the trial, participants will receive the study drugs and will be monitored closely by the medical team. It's important to note that women who can get pregnant will need to take precautions to prevent pregnancy during the study. This trial is currently recruiting participants, so if you think it might be a good fit, it could be worth discussing with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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.
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