Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 22, 2016

Primary Completion Date

April 8, 2019

Study Completion Date

April 8, 2019

Conditions
Lymphoma
Interventions
DRUG

Lenalidomide

"Dose Escalation Phase Starting dose of Lenalidomide: 50 mg by mouth on Days -9 to -2.~Dose Expansion Phase Starting Dose: Maximum tolerated dose from Phase I."

DRUG

Vorinostat

1000 mg by mouth on Days -9 to -2.

DRUG

Gemcitabine

Gemcitabine administered as a loading dose of 75 mg/m2 by vein on Day -8 and 2775 mg by vein on Day -3.

DRUG

Busulfan

"Busulfan test dose administered by vein either as outpatient before admission, or as inpatient on day -10. The test dose of 32 mg/m2 based on actual body weight. Doses of days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1."

DRUG

Melphalan

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

DRUG

Rituximab

Patients with CD20+ tumors receive Rituximab 375 mg/m2 by vein on day -9 in the AM as an inpatient.

DRUG

Dexamethasone

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

DRUG

Caphosol

Caphosol oral rinses 30 mL four times a day used from Day -8.

DRUG

Glutamine

Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.

DRUG

Pyridoxine

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

DRUG

Enoxaparin

40 mg subcutaneously daily from admission until platelet count drops below 50,000/mm3.

PROCEDURE

Stem Cell Transplant

Stem cell transplant performed on Day 0.

DRUG

Palifermin

Palifermin per departmental standard of care with 3 doses to be administered prior to starting chemotherapy and 3 doses starting on day 0.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER