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Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

NCT00290433 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-09-23

Study results available
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Summary

The goal of this clinical research study is to learn if treatment with two types of chemotherapy combinations can help to control peripheral T-cell lymphoma.

Conditions

Interventions

DRUG

Cyclophosphamide

Cycle 1: 300 mg/m\^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.

DRUG

Mesna

Cycle 1: 600 mg/m\^2 by vein Continuous Infusion Over Days 1, 2, and 3.

DRUG

Vincristine

Cycle 1: 1.4 mg/m\^2 by vein On Day 4 and 11.

DRUG

Methotrexate

Cycle 1 and 2: 200 mg/m\^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m\^2 IV Over 22 Hours on Day 1.

DRUG

Ara-C

Cycle 1 and 2: 3 Gm/m\^2 Over 2 Hours Twice Daily On Days 2 and 3.

DRUG

Dexamethasone

Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.

DRUG

G-CSF

Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.

DRUG

Doxil

Cycle 1: 25 mg/m\^2 by vein Over 1 Hour on Day 2.

Sponsors & Collaborators

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Yasuhiro Oki, MD · M.D. 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
2003-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00290433 on ClinicalTrials.gov