MedTrace Logo

Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory Diffuse Large b Cell Lymphoma (DLBCL)

NCT01120834 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-04-10

Study results available
· View outcomes & findings →

Summary

This will be a phase I/II study of 5-azacitidine in combination with vorinostat in patients with relapsed or refractory DLBCL. Combination therapy with methyltransferase inhibitors and histone deacetylase inhibitors is highly synergistic in DLBCL cells, and both classes of drugs can also synergize powerfully with standard anti-lymphoma chemotheraputics such as doxorubicin in pre-clinical studies. We hypothesize that azacytidine + vorinostat combination therapy will be safe and effective in selected patients with relapsed or refractory DLBCL. We also hypothesize that patients demonstrating objective responses to this combination therapy display specific epigenetic signatures, and that a biomarker or gene classifier can be generated which will identify those patients likely to respond.

Conditions

Interventions

DRUG

azacytidine

* Dose level 1: azacitidine 55 mg/m2 on days 1-5 * Dose level 2: azacitidine 75 mg/m2 on days 1-5 * Dose level 3: azacitidine 55 mg/m2 on days 1-5 * Dose level 4: azacitidine 75 mg/m2 on days 1-5 Each cycle = 28 days. Subjects may receive up to 6 cycles.

DRUG

vorinostat

* Dose level 1: oral vorinostat at 300 mg BID on Days 1-7. * Dose level 2: oral vorinostat at 200 mg BID on Days 1-7. * Dose level 3: oral vorinostat at 300 mg BID on Days 1-14. * Dose level 4: oral vorinostat at 200 mg BID on Days 1-14. Each cycle = 28 days. Subjects receive up to 6 cycles.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Peter Martin, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-04-30
Completion
2016-10-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01120834 on ClinicalTrials.gov