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

Phase 2

• Conditions: Hodgkin's Lymphoma
• Interventions: Drug: Oxaliplatin-based chemotherapy (ESHAOx)

• Registration Number: NCT01300156
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-02
• Study Start: 2011-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Last Update Submitted: 2011-02-18
• Study First Posted: 2011-02-21
• Last Update Posted: 2011-02-21
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESHAOx arm	Oxaliplatin-based chemotherapy (ESHAOx)	Patients who are planned to be treated with ESHAOx chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall Response rate to ESHAOx chemotherapy	within 3 weeks after the completion of the treatment	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival, response duration, toxicity profiles	up to 5 years after the completion of treatment

Trial Locations

Locations (1)

National Cancer Center, Korea; 🇰🇷 Goyang, Korea, Republic of