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

NCT00930605 | Completed Phase 2

• 1 other identifier: TH011001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• The response to treatment and the treatment-related toxicity.

  3 years

Study Arms (1)

Alemtuzumab combination with CHOP and ESHAP

EXPERIMENTAL

Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5. CHOP alternate with ESHAP is given every 21 days for a total of 6 course.

Drug: CHOP regimen alternate with ESHAP regimen; Drug: Alemtuzumab

Interventions

CHOP regimen alternate with ESHAP regimen DRUG

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

Alemtuzumab combination with CHOP and ESHAP

Alemtuzumab DRUG

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

Alemtuzumab combination with CHOP and ESHAP

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Newly diagnosed, age 15 - 65 years.
• Complete work up for baseline evaluation and measurement (Appendix B).
• Patient's free written inform consent.

You may not qualify if:

• 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 human immunodeficiency virus exposure.
• 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.
• Pregnant or lactating women.
• Serious medical or psychiatric illness which prevent informed consent.
• Patients who are likely to lost to follow up (e.g., unwilling or difficult to return, cannot be contacted).

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead
• Bayer: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

ESHAP regimen; Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tanin Intragumtornchai, M.D.

  Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: January 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: July 1, 2008
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

TH (1)