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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)

Primary Purpose

Peripheral T-cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

CHOP regimen alternate with ESHAP regimen

Alemtuzumab

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma

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
  - 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.
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 human immunodeficiency virus exposure.
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.
Pregnant or lactating women.
Serious medical or psychiatric illness which prevent informed consent.
Patients who are likely to lost to follow up (e.g., unwilling or difficult to return, cannot be contacted).

Sites / Locations

King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alemtuzumab combination with CHOP and ESHAP

Arm Description

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.

Outcomes

Primary Outcome Measures

The response to treatment and the treatment-related toxicity.

Secondary Outcome Measures

Full Information

NCT ID

NCT00930605

First Posted

June 29, 2009

Last Updated

October 4, 2011

Sponsor

King Chulalongkorn Memorial Hospital

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00930605

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Chulalongkorn Memorial Hospital

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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? Secondary Research Question What is the incidence of life-threatening toxicities (grade 3 and 4, according to WHO criteria, Appendix A) in the patients?

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alemtuzumab combination with CHOP and ESHAP

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

CHOP regimen alternate with ESHAP regimen

Intervention Description

CHOP alternate with ESHAP is given every 21 days for a total of 6 course.

Intervention Type

Drug

Intervention Name(s)

Alemtuzumab

Intervention Description

Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5.

Primary Outcome Measure Information:

Title

The response to treatment and the treatment-related toxicity.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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. 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 human immunodeficiency virus exposure. 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. Pregnant or lactating women. Serious medical or psychiatric illness which prevent informed consent. Patients who are likely to lost to follow up (e.g., unwilling or difficult to return, cannot be contacted).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tanin Intragumtornchai, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

King Chulalongkorn Memorial Hospital

City

Bangkok

Country

Thailand

12. IPD Sharing Statement

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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)

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