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

Phase 2
15 Years
65 Years
Not Enrolling
Peripheral T-cell Lymphoma

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Trial Information

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

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.

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

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

2. Patients who have received prior antilymphoma treatment with chemotherapy or

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

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).

Type of Study:


Study Design:

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

Outcome Measure:

The response to treatment and the treatment-related toxicity.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Tanin Intragumtornchai, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University


Thailand: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

July 2008

Related Keywords:

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