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

Summary

The goal of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination 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 effectiveness of this combination.

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.

Sponsors & Collaborators

• Celgene Corporation

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Yago Nieto, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-22

Primary Completion

2019-04-08

Completion

2019-04-08

FDA Drug

Yes

Countries

• United States

Study Locations