Phase 2 Completed N=27 Treatment

Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)

Non-Hodgkin's Lymphoma

Source: ClinicalTrials.gov NCT00336583 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Jun 2010

Primary outcomePrimary: Overall Response Rate — 17 pariticipants

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 regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate	17	—
SECONDARY Worst Toxicity Grade by Patient	3; 3; 2; 13; 4; 3	—

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00336583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.