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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT01120834
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • azacytidine — DRUG
    * 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.
  • vorinostat — DRUG
    * 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2010
Status verified
Feb 2017
Primary completion
Apr 30, 2013
Completion
Oct 20, 2016

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: all subjects

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 2 cycles ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Weill Cornell Medical College· New York, NY

Related Studies