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CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

NCT00323323 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-01-20

No results posted yet for this study

Summary

Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments. The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

CHOP

CHOP will be given 60-120 minutes following SQ administration of Alemtuzumab as follows: cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, vincristine 1.4 mg/m2 (maximum dose = 2 mg) IV on day 1, and prednisone 100 mg PO on days 1-5.

DRUG

Alemtuzumab

Single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5.

PROCEDURE

Plasma Samples

Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Pierluigi Porcu, MD · Ohio State 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
2004-03-31
Primary Completion
2012-08-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

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 NCT00323323 on ClinicalTrials.gov