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

NCT00441025 | Terminated Phase 2

• 1 other identifier: TH 011002
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T-Cell Lymphoma

Keywords

MabCampath + CHOP in PTCL

Outcome Measures

Primary Outcomes (3)

• To determine the effectiveness of alemtuzumab given in combination with CHOP in terms of the rates of objective response rate (ORR:complete remission[CR] and

• partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS)

• in patients newly diagnosed with PTCL.

Secondary Outcomes (1)

• To determine the safety profiles of alemtuzumab given in combination with CHOP

Study Arms (1)

1

ACTIVE COMPARATOR

1 Alemtuzumab

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

1

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
• 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 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).

Sponsors & Collaborators

• Mahidol University: lead
• Bayer: collaborator

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

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

• Surapol Issaragrisil, M.D.,Prof.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: September 1, 2006
• Study Completion: August 1, 2009
• Last Updated: June 25, 2009

Record last verified: 2007-02

Locations

TH (1)