The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL)
NCT ID: NCT00930605
Last Updated: 2011-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2005-01-31
2008-07-31
Brief Summary
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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?
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
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).
15 Years
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
King Chulalongkorn Memorial Hospital
OTHER
Responsible Party
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Prof.Tanin Intragumtornchai
Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Principal Investigators
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Tanin Intragumtornchai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Locations
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King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Countries
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Other Identifiers
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TH011001
Identifier Type: -
Identifier Source: org_study_id