Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Johns Hopkins All Children's Hospital
Study ID
NCT03843528
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    Vorinostat will be administered concurrent with low-dose azacitidine post-transplant, on days 1-7 and 15-21 of 28 day cycles. This is an oral medication.
  • Azacitidine Injection — DRUG
    Azacitidine will be administered on days 1-5 of each 28 day cycle, either by IV or subcutaneous injection. The dose of azacitidine will be fixed, with no dose-escalation.

Study Details

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.

Key Dates

Start date
May 1, 2019
Status verified
Aug 2025
Primary completion
Jul 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combined therapy
    Patients will be enrolled in blocks of 3, with vorinostat dose-escalation according to 3+3 study design. Low-dose azacitidine will be administered in a fixed dose to all patients, for days 1-5 of each 28 day cycle.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-

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By research site
Johns Hopkins All Children's Hospital· St. Petersburg, FL

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