Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma

Summary

The goal of this clinical research study is to learn about the safety and effectiveness of the combination of panobinostat, gemcitabine, busulfan, and melphalan, either with or without rituximab, in patients who have non-Hodgkin's or Hodgkin's lymphoma and are receiving a stem cell transplant.

Conditions

• Lymphoma

Interventions

DRUG

Palifermin

Palifermin, per standard of care, on Days -13 to -11 and on Days 0, +1, and +2.

DRUG

Panobinostat

20 mg by mouth daily from Day -9 to -2.

DRUG

Gemcitabine

Gemcitabine administered as a loading dose of 75 mg/m2 by vein followed by prolonged infusion over 4.5 hours of 2,700 mg/m2 (total daily dose 2,775 mg/m2) on Days -8 and -3.

DRUG

Busulfan

Busulfan "test dose" administered on Day -10. Test dose of 32 mg/m2 based on actual body weight administrated over 60 minutes. Busulfan pharmacokinetics performed with the test dose and the first dose on Day-8. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.

DRUG

Melphalan

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

DRUG

Rituximab

375 mg/m2 by vein on Day -9 for patients with CD20+ tumors.

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.

OTHER

Oral Cryotherapy (ice chips)

Oral cryotherapy (ice chips) from 30 minutes before until 2 hours after each Melphalan infusion.

DRUG

Pyridoxine

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

BIOLOGICAL

Stem Cell Infusion

Stem cells administered by vein on Day 0.

DRUG

G-CSF

G-CSF administered as an injection just under the skin, per standard of care ,1 time each day starting on Day +5 until blood cell levels return to normal.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-30

Primary Completion

2021-06-30

Completion

2021-06-30

FDA Drug

Yes