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Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma

NCT02701673 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-05-04

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of belinostat that can be given in combination with azacitidine, gemcitabine, busulfan, and melphalan to patients who are scheduled to have a stem cell transplant. If you have diffuse large B-cell lymphoma (DLBCL), you will also receive rituximab. Researchers also want to learn about the safety and effectiveness of this combination.

Conditions

Interventions

DRUG

Busulfan

Busulfan "test dose" administered by vein on Day -10. Test dose of 32 mg/m2 based on actual body weight. Busulfan pharmacokinetics performed with the test dose and the first dose on Day -8. Doses on Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1.

DRUG

Caphosol

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

DRUG

Glutamine

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

DRUG

Pyridoxine

Pyridoxine 100 mg by vein or mouth three times a day staring on Day -1

DRUG

Belinostat

Starting dose of Belinostat 100 mg/ m2/day by vein on Day -9 through Day -2.

DRUG

Azacitidine

Azacitidine 15 mg/m2/day by vein on Day -9 through Day -2.

DRUG

Gemcitabine

Gemcitabine 75 mg/m2 by vein administered as a loading dose followed by prolonged infusion on Days -8 and -3.

DRUG

Melphalan

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

PROCEDURE

Stem Cell Transplant

Stem cell transplant performed on Day 0.

Sponsors & Collaborators

  • 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
2016-06-30
Primary Completion
2019-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701673 on ClinicalTrials.gov