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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Hodgkin's Lymphoma

Treatments: Drug: Oxaliplatin-based chemotherapy (ESHAOx)

Study type: Interventional

Funder types: Other

Identifiers

NCT01300156

NCCCTS-10-524

Details and patient eligibility

About

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).

Enrollment: 37 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

ESHAOx arm

Experimental group

Description:

Patients who are planned to be treated with ESHAOx chemotherapy

Treatment:

Drug: Oxaliplatin-based chemotherapy (ESHAOx)