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

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ClinicalTrials.gov Identifier: NCT00441025
Recruitment Status : Terminated (a lack of a potential patient.)
First Posted : February 27, 2007
Last Update Posted : June 25, 2009
Sponsor:
Collaborator:
Bayer
Information provided by:
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Peripheral T-Cell Lymphoma Drug: Alemtuzumab Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2006
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Alemtuzumab

Arm Intervention/treatment
Active Comparator: 1
1 Alemtuzumab
Drug: Alemtuzumab



Primary Outcome Measures :
  1. 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
  2. partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS)
  3. in patients newly diagnosed with PTCL.

Secondary Outcome Measures :
  1. To determine the safety profiles of alemtuzumab given in combination with CHOP


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00441025     History of Changes
Other Study ID Numbers: TH 011002
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: February 2007

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
Antineoplastic Agents