At a glance
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Azacitidine/Vorinostat/GemBuMel With Autologous Stem-Cell Transplant (SCT) in Patients With Refractory Lymphomas
In Brief
A Phase 2 clinical trial evaluating Azacitidine, Vorinostat, and 8 other interventions for Advanced Cancers and Lymphoma. Completed, enrolled 61 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to find the highest tolerable dose of azacitidine that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want to learn about the safety and level of effectiveness of this combination.
Study Details
Timeline
Interventions
Starting dose 15 mg/ m2 by vein on Day -11.
1000 mg by vein on Day -11 through Day -2.
Loading dose 75 mg/m2 by vein followed by 22775 mg/m2 by vein on Day -8.
Busulfan test dose 32 mg/m2 by vein either as outpatient before Day -12 or as inpatient on Day -11. Busulfan pharmacokinetics performed with test dose and first dose on Day -8. Doses on Days -6 and -5 adjusted to target an AUC of 4,000 microMol.min-1.
60 mg/m2 by vein on Days -3 and -2.
8 mg by vein twice a day from Day -11 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -9.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed from Day -9.
100 mg by vein or mouth three times a day from Day -1.
375 mg/m2 by vein on Days -9.