The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL

NCT ID: NCT00441025

Last Updated: 2009-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-08-31

Brief Summary

The purpose of this study is to determine whether the treatment of Alemtuzumab in combination with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first line treatment in patients with peripheral T-cell lymphoma.

Detailed Description

Peripheral T-cell lymphomas (PTCL) are more common in Asia than in Europe and United States (17-40% vs. 5-10%). Most studies reported a poorer prognosis for PTCL compared to B-cell non-Hodgkin's lymphomas (NHL).

CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) is currently regarded as a standard chemotherapy regimen for patients with newly diagnosed NHL.

Alemtuzumab (Campath-1H) is a humanized monoclonal antibody that targets CD52, a cell surface protein present at high density on most normal and malignant B and T lymphocytes.Malignant T cells express particularly high numbers of CD52 cell surface markers (approximately 500,000 molecules/lymphocytes),T-cell malignancies may thus be particularly responsive to alemtuzumab.

As the response rate tend to be higher in patients newly diagnosed with PTCL, this study evaluates the efficacy of alemtuzumab in combination with CHOP administered as up-front therapy in patients newly diagnosed with PTCL in terms of response rate and overall survival.

Conditions

Peripheral T-Cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

1 Alemtuzumab

Group Type: ACTIVE_COMPARATOR

Alemtuzumab

Intervention Type: DRUG

Interventions

Alemtuzumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must have a diagnosis of one of the following histologic types according to the WHO classification:

• Angioimmunoblastic T-cell lymphoma
• Extranodal NK/T-cell lymphoma,nasal type
• Enteropathy-type T-cell lymphoma
• Hepatosplenic gamma-delta T-cell lymphoma
• Subcutaneous panniculitis-like T-cell lymphoma
• Anaplastic large-cell lymphoma,T/null cell,primary systemic type
• Peripheral T-cell lymphoma,not otherwise characterized
• Newly diagnosed,age 15-65 years.
• Complete work up for baseline evaluation and measurement (Appendix B)
• Patient's free written inform consent.

Exclusion Criteria

• Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.
• Patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy
• Patients with poor performance status (PS;ECOG criteria of 3-4)(Appendix C).
• Serologic evidence of HCV and HCV RNA of chronic hepatitis.
• Serologic evidence of HBV and HBV RNA of chronic hepatitis.
• Patients with history of impaired cardiac status or myocardial infarction.
• Patients with serum creatinine >= 1.8 mg/dl,bilirubin >= 1.5 times upper limit of normal range,SGOT or SGPT >= 3 times upper limit of normal range, unless due to tumor involvement.
• Patients with active uncontrolled infection,active non-malignant gastric or duodenal ulcer, uncontrolled diabetes mellitus or other severe medical conditions which would preclude aggressive cytotoxic chemotherapy.
• Active secondary malignancy.
• Pregnant or lactating women.
• Serious medical or psychiatric illness which prevent informed consent.
• Patients who are likely to lost to follow up (eg, unwilling or difficult to return,cannot be contacted).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Principal Investigators

Surapol Issaragrisil, M.D.,Prof.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

Other Identifiers

TH 011002

Identifier Type: -

Identifier Source: org_study_id