Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma (HL).

Official Title
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A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)

Conditions
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Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Oxaliplatin-based chemotherapy (ESHAOx)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously histologically confirmed Hodgkin's lymphoma Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease Performance status (ECOG) ≤ 3 Age ≤ 75 years old Number of prior chemotherapies: one or two regimens 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/dL Written informed consent approved by institutional review board or ethic committee Exclusion Criteria: Previous high dose chemotherapy with autologous stem cell transplantation or allogeneic stem cell transplantation Previous chemotherapies with ESHAP regimen Any other malignancies within the past 5 years except skin basal cell carcinoma or carcinoma in situ of cervix Other serious illness or medical conditions Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry History of significant neurologic or psychiatric disorders including dementia or seizures Active uncontrolled infection (viral, bacterial or fungal infection) Other serious medical illnesses Pregnancy or breast-feeding, women of childbearing potential not employing adequate contraception Previous history of drug allergy to one of the drugs in the study regimen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESHAOx arm<br>Patients who are planned to be treated with ESHAOx chemotherapy | Drug: Oxaliplatin-based chemotherapy (ESHAOx)<br>* Etoposide 40 mg/m2, D1-4 Methylprednisolone 500mg, D1-5 Cytarabine 2 g/m2, D5 Oxaliplatin 130 mg/m2, D1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response rate to ESHAOx chemotherapy | To evaluate response rate by Cheson criteria for malignant lymphoma after 3 and 6 cycles of treatment with ESHAOx regimen in patients with refractory or relapsed Hodgkin's lymphoma. | within 3 weeks after the completion of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, response duration, toxicity profiles |  | up to 5 years after the completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin's disease, lymphoma, Relapsed, refractory