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The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL) (C+CHOP/ESHAP)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Prof.Tanin Intragumtornchai, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00930605
First received: June 29, 2009
Last updated: October 4, 2011
Last verified: October 2011
  Purpose
  1. Primary Research Question What are the rates of complete response (CR), partial response (PR), progression free survival (PFS) and overall survival (OS) in adult patients newly diagnosed with Peripheral T-Cell Lymphoma (PTCL) who are treated with alemtuzumab given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) and ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) administered as an up-front treatment?
  2. Secondary Research Question What is the incidence of life-threatening toxicities (grade 3 and 4, according to WHO criteria, Appendix A) in the patients?

Condition Intervention Phase
Peripheral T-cell Lymphoma
Drug: CHOP regimen alternate with ESHAP regimen
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 and ESHAP as First-Line Treatment in Peripheral T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by King Chulalongkorn Memorial Hospital:

Primary Outcome Measures:
  • The response to treatment and the treatment-related toxicity. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: January 2005
Study Completion Date: July 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alemtuzumab combination with CHOP and ESHAP
Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5. CHOP alternate with ESHAP is given every 21 days for a total of 6 course.
Drug: CHOP regimen alternate with ESHAP regimen
CHOP alternate with ESHAP is given every 21 days for a total of 6 course.
Drug: Alemtuzumab
Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5.

Detailed Description:

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.

CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) is currently regarded as a standard chemotherapy regimen for patients with newly diagnosed NHL.

ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) chemotherapy was invented in 1994. The regimen was aimed to salvage NHL patients who were relapsing or refractory to front-line, mostly doxorubicin-based, chemotherapy.Major toxicities were myelosuppression; 30% of the patients developed febrile neutropenia and was admitted for parenteral antibiotics. Treatment-related deaths, mostly from uncontrolled sepsis, occurred in 4% of the patients. Because of its efficacy and tolerable toxicities, at present, ESHAP is one of the salvage chemotherapy regimens most frequently administered to patients especially prior to autologous stem cell transplantation.

Recently, our unit had reported the efficacy of the combination of standard CHOP chemotherapy and ESHAP and high-dose therapy with autologous stem cell transplantation or rituximab given as upfront therapy in patients newly diagnosed as poor prognosis aggressive NHL (high- and high-intermediate risk groups according to the international index).15,16 According to the previous institutional experience as well as the efficacy of the combination of CHOP and ESHAP in patients with high-risk aggressive lymphoma, we would like therefore to determine the outcome of alemtuzumab given in combination with CHOP and ESHAP in patients newly diagnosed with PTCL, the effectiveness of which has not been known.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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

      • All biopsy specimens including patients whose diagnosis have been made outside King Chulalongkorn Memorial Hospital will be reviewed by an expert hematopathologist at Department of Pathology, King Chulalongkorn Memorial Hospital.
  2. Newly diagnosed, age 15 - 65 years.
  3. Complete work up for baseline evaluation and measurement (Appendix B).
  4. Patient's free written inform consent.

Exclusion Criteria:

  1. Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.
  2. Patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy.
  3. Patients with poor performance status (PS; ECOG criteria of 3-4)(Appendix C).
  4. Serologic evidence of human immunodeficiency virus exposure.
  5. Patients with history of impaired cardiac status or myocardial infarction.
  6. 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.
  7. 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.
  8. Pregnant or lactating women.
  9. Serious medical or psychiatric illness which prevent informed consent.
  10. Patients who are likely to lost to follow up (e.g., 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: NCT00930605

Locations
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Bayer
Investigators
Principal Investigator: Tanin Intragumtornchai, M.D. Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
  More Information

No publications provided

Responsible Party: Prof.Tanin Intragumtornchai, Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT00930605     History of Changes
Other Study ID Numbers: TH011001
Study First Received: June 29, 2009
Last Updated: October 4, 2011
Health Authority: Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Alemtuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014