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SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma

NCT00787527 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-09-09

Study results available
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Summary

The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied.

Conditions

Interventions

DRUG

Zolinza (vorinostat)

Up to two 100 mg capsules of Vorinostat (dosage will vary from 100 mg orally (PO) twice daily (BID), 300 mg PO every evening and 200 mg PO BID with the starting dose at 300 mg PO every evening for the phase I trial) are to be administered orally twice daily (once in the morning and once in the evening, or if in the daily dosing cohort once in the evening) in repeated 21-day cycles consisting of 10 days dosing starting on days 5 through 14 followed by a 7-day rest period, during which no vorinostat will be administered.

DRUG

Cyclophosphamide

750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle

DRUG

Doxorubicin

50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle

DRUG

Vincristine

1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle

DRUG

Prednisone

100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

Sponsors & Collaborators

Principal Investigators

  • Yasuhiro Oki, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00787527 on ClinicalTrials.gov