Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01983969
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Starting dose 15 mg/ m2 by vein on Day -11.
  • Vorinostat — DRUG
    1000 mg by vein on Day -11 through Day -2.
  • Gemcitabine — DRUG
    Loading dose 75 mg/m2 by vein followed by 22775 mg/m2 by vein on Day -8.
  • Busulfan — DRUG
    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.
  • Melphalan — DRUG
    60 mg/m2 by vein on Days -3 and -2.
  • Dexamethasone — DRUG
    8 mg by vein twice a day from Day -11 AM to Day -2 PM.
  • Caphosol — OTHER
    Caphosol oral rinses 30 mL four times a day used from Day -9.
  • Glutamine — DRUG
    Oral glutamine, 15 g four times a day, swished, gargled and swallowed from Day -9.
  • Pyridoxine — DRUG
    100 mg by vein or mouth three times a day from Day -1.
  • Rituximab — DRUG
    375 mg/m2 by vein on Days -9.

Study Details

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.

Key Dates

Start date
Nov 7, 2013
Status verified
Jan 2020
Primary completion
Nov 22, 2017
Completion
Nov 22, 2017

Study Design

Enrollment
61 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine + Vorinostat + Gemcitabine + Busulfan + Melphalan
    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. Dexamethasone 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. Pyridoxine 100 mg by vein or mouth three times a day from Day -1. Vorinostat 1000 mg by vein on Day -11 through Day -2. Gemcitabine loading dose 75 mg/m2 by vein followed by 22775 mg/m2 by vein on Day -8. Melphalan 60 mg/m2 by vein on Days -3 and -2. Azacitidine starting dose 15 mg/ m2 by vein on Day -11. Stem cell transplant on Day 0. Patients with CD20+ tumors receive rituximab 375 mg/m2 by vein on Days -9.

Primary Outcome Measure

Frequency of DLT [ Time Frame: Enrollment up to day 30 post transplant for each dosing cohort ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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