Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

November 7, 2013

Primary Completion Date

November 22, 2017

Study Completion Date

November 22, 2017

Conditions
Advanced CancersLymphoma
Interventions
DRUG

Azacitidine

Starting dose 15 mg/ m2 by vein on Day -11.

DRUG

Vorinostat

1000 mg by vein on Day -11 through Day -2.

DRUG

Gemcitabine

Loading dose 75 mg/m2 by vein followed by 22775 mg/m2 by vein on Day -8.

DRUG

Busulfan

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.

DRUG

Melphalan

60 mg/m2 by vein on Days -3 and -2.

DRUG

Dexamethasone

8 mg by vein twice a day from Day -11 AM to Day -2 PM.

OTHER

Caphosol

Caphosol oral rinses 30 mL four times a day used from Day -9.

DRUG

Glutamine

Oral glutamine, 15 g four times a day, swished, gargled and swallowed from Day -9.

DRUG

Pyridoxine

100 mg by vein or mouth three times a day from Day -1.

DRUG

Rituximab

375 mg/m2 by vein on Days -9.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT01983969 - Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma | Biotech Hunter | Biotech Hunter