search
Back to results

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

Primary Purpose

Peripheral T-Cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Alemtuzumab
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-Cell Lymphoma focused on measuring MabCampath + CHOP in PTCL

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

1 Alemtuzumab

Outcomes

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

Full Information

First Posted
February 26, 2007
Last Updated
June 24, 2009
Sponsor
Mahidol University
Collaborators
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT00441025
Brief Title
The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL
Official Title
A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Why Stopped
a lack of a potential patient.
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University
Collaborators
Bayer

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-Cell Lymphoma
Keywords
MabCampath + CHOP in PTCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
1 Alemtuzumab
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab
Primary Outcome Measure Information:
Title
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
Title
partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS)
Title
in patients newly diagnosed with PTCL.
Secondary Outcome Measure Information:
Title
To determine the safety profiles of alemtuzumab given in combination with CHOP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surapol Issaragrisil, M.D.,Prof.
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs