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

This study has been terminated.
(a lack of a potential patient.)
Sponsor:
Collaborator:
Bayer
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00441025
First received: February 26, 2007
Last updated: June 24, 2009
Last verified: February 2007
  Purpose

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.


Condition Intervention Phase
Peripheral T-Cell Lymphoma
Drug: Alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To determine the safety profiles of alemtuzumab given in combination with CHOP

Enrollment: 4
Study Start Date: September 2006
Estimated Study Completion Date: August 2009
Arms Assigned Interventions
Active Comparator: 1
1 Alemtuzumab
Drug: Alemtuzumab

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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441025

Locations
Thailand
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Bayer
Investigators
Principal Investigator: Surapol Issaragrisil, M.D.,Prof. Siriraj Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00441025     History of Changes
Other Study ID Numbers: TH 011002
Study First Received: February 26, 2007
Last Updated: June 24, 2009
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
MabCampath + CHOP in PTCL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014