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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Chulalongkorn Memorial Hospital
• Collaborator: Bayer
• Treatments: Alemtuzumab

Criteria

Inclusion Criteria:

1. 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

• All biopsy specimens including patients whose diagnosis have been made outside King Chulalongkorn Memorial Hospital will be reviewed by an expert hematopathologist at Department of Pathology, King Chulalongkorn Memorial Hospital.

2. Newly diagnosed, age 15 - 65 years.

3. Complete work up for baseline evaluation and measurement (Appendix B).

4. Patient's free written inform consent.

Exclusion Criteria:

1. Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.

2. Patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy.

3. Patients with poor performance status (PS; ECOG criteria of 3-4)(Appendix C).

4. Serologic evidence of human immunodeficiency virus exposure.

5. Patients with history of impaired cardiac status or myocardial infarction.

6. 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.

7. 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.

8. Pregnant or lactating women.

9. Serious medical or psychiatric illness which prevent informed consent.

10. Patients who are likely to lost to follow up (e.g., unwilling or difficult to return, cannot be contacted).