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Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma

NCT01983969 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-01-27

Study results available
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Summary

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

Conditions

Interventions

DRUG

Azacitidine

Starting dose 15 mg/ m2 by vein on Day -11.

DRUG

Vorinostat

1000 mg by vein on Day -11 through Day -2.

DRUG

Gemcitabine

Loading dose 75 mg/m2 by vein followed by 22775 mg/m2 by vein on Day -8.

DRUG

Busulfan

Busulfan test dose 32 mg/m2 by vein either as outpatient before Day -12 or as inpatient on Day -11. Busulfan pharmacokinetics performed with test dose and first dose on Day -8. Doses on Days -6 and -5 adjusted to target an AUC of 4,000 microMol.min-1.

DRUG

Melphalan

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

DRUG

Dexamethasone

8 mg by vein twice a day from Day -11 AM to Day -2 PM.

OTHER

Caphosol

Caphosol oral rinses 30 mL four times a day used from Day -9.

DRUG

Glutamine

Oral glutamine, 15 g four times a day, swished, gargled and swallowed from Day -9.

DRUG

Pyridoxine

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

DRUG

Rituximab

375 mg/m2 by vein on Days -9.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-07
Primary Completion
2017-11-22
Completion
2017-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01983969 on ClinicalTrials.gov