Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Lymphoma
Interventions
DRUG

Vorinostat

Starting dose: 200 mg by mouth on Days -8 to -2.

DRUG

Gemcitabine

Starting dose: 2175 mg/m2 by vein on Days -8 and -3. This includes the gemcitabine 75 mg/m2 loading dose.

DRUG

Busulfan

"AUC: 4,000 micrometer (microM).min/day, or 105 mg/m2/day) on Days -8 to -5.~Pharmacokinetics will be performed with the first dose of 32 mg/m2 by vein on Day -8. The doses on Days -6 and -5 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting not possible, a dose of busulfan of 105 mg/m2 will be administered on days -6 and -5."

DRUG

Melphalan

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

PROCEDURE

Stem Cell Infusion

Infusion of stem cells by vein on Day 0.

DRUG

Rituximab

375 mg/m2 on days +1 and +8 for patients with CD20+ tumors.

DRUG

G-CSF

5 mcg/kg/day (rounded up the nearest vial) subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.

DRUG

Palifermin

60 mcg/kg by vein daily for 6 doses. Three doses administrated prior to start chemo (24 hours must elapse between the last dose and first therapeutic dose of chemo) and three doses after the last chemo starting on day 0.

DRUG

Dexamethasone acetate

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

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT01421173 - Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies | Biotech Hunter | Biotech Hunter