Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patient… (NCT01789255) | Clinical Trial Compass
CompletedPhase 2
Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies
United States12 participantsStarted 2013-06
Plain-language summary
This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an effective treatment for GVHD caused by a bone marrow transplant.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* A prospective patient for allogeneic HSCT for hematologic conditions, both malignant and non-malignant; donor can be unrelated marrow or peripheral blood cells; a patient with history of central nervous system (CNS) involvement is eligible if CNS disease is in remission at time of study consideration
* The donor and recipient must have a human leukocyte antigen (HLA)-8/8 allelic match at the HLA-A, -B, -C, and -DRB1; high-resolution typing is required for all alleles
* Diagnoses to be included:
* Acute myelogenous leukemia at the following stages:
* First remission
* Second or subsequent remission
* Complete remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment and \< 5% blasts in the bone marrow
* Chronic myelogenous leukemia at the following stages:
* First or subsequent chronic phase:
* Patient refused tyrosine kinase therapy or is otherwise not suited for it
* Stable, not hematologic remission: blasts present in marrow and/or peripheral blood, but disease does not qualify as accelerated or blast phase
* Hematologic remission: no blast cells or precursor cells in the blood or marrow
* Partial cytogenetic remission: Philadelphia chromosome positive (Ph+) metaphases \> 0% but \< 35%
* Complete cytogenetic remission: absence of Ph+ metaphases
* Accelerated phase - any one of the following symptoms:
* White blood cells (WBC) difficult to control (\> 50 x 10\^9/L despite…
What they're measuring
1
The Number of Participants That Experience Grade 2-4 Acute GVHD (Graft Versus Host Disease) by Day 100