Status:
COMPLETED
Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Boryung Pharmaceutical Co., Ltd
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage re...
Detailed Description
Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy considered curable in many cases. However, diagnosis of refractory or relapsed disease is devastating and the treat...
Eligibility Criteria
Inclusion
- Previously histologically confirmed aggressive lymphomas, defined according to WHO classification (except Burkitt's lymphoma, lymphoblastic lymphoma)
- Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease
- Performance status (ECOG) ≤3
- Age ≤ 75
- Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen
- At least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
- Adequate organ functions defined as; ANC \> 1,500/ul, platelet \> 75,000/ul, transaminases \< 3 X upper normal values; bilirubin \< 2 mg%
- Written informed consent approved by Institutional Review Board
Exclusion
- Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
- Serious co-morbid diseases
- Pregnancy or breast-feeding
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00336583
Start Date
June 1 2006
End Date
January 1 2008
Last Update
June 26 2018
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736