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

Peripheral T-cell Lymphoma Clinical Trial

— C+CHOP/ESHAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930605
• Other study ID #: TH011001
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2009
• Last updated: October 4, 2011
• Start date: January 2005
• Est. completion date: July 2008

Study information

• Verified date: October 2011
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2008
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• CHOP regimen alternate with ESHAP regimen
CHOP alternate with ESHAP is given every 21 days for a total of 6 course.
• Alemtuzumab
Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital	Bayer

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The response to treatment and the treatment-related toxicity.		3 years	Yes