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

Peripheral T-Cell Lymphoma Clinical Trial

Official title:

A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00441025
• Other study ID #: TH 011002
• Status: Terminated
• Phase: Phase 2
• First received: February 26, 2007
• Last updated: June 24, 2009
• Start date: September 2006
• Est. completion date: August 2009

Study information

• Verified date: February 2007
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-Cell Lymphoma

Intervention

Drug:
• Alemtuzumab

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Bayer

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS)
Primary	in patients newly diagnosed with PTCL.
Secondary	To determine the safety profiles of alemtuzumab given in combination with CHOP