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The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL)

NCT00930605 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-10-06

No results posted yet for this study

Summary

1. Primary Research Question What are the rates of complete response (CR), partial response (PR), progression free survival (PFS) and overall survival (OS) in adult patients newly diagnosed with Peripheral T-Cell Lymphoma (PTCL) who are treated with alemtuzumab given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) and ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) administered as an up-front treatment?
2. Secondary Research Question What is the incidence of life-threatening toxicities (grade 3 and 4, according to WHO criteria, Appendix A) in the patients?

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

CHOP regimen alternate with ESHAP regimen

CHOP alternate with ESHAP is given every 21 days for a total of 6 course.

DRUG

Alemtuzumab

Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Principal Investigators

  • Tanin Intragumtornchai, M.D. · Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2006-11-30
Completion
2008-07-31

Countries

  • Thailand

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 NCT00930605 on ClinicalTrials.gov