Clinical trial NCT01300156: Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)
Official title: A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's disease
lymphoma
Relapsed
refractory
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Asan Medical Center
name: Severance Hospital
First posted: 2011-02-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response rate to ESHAOx chemotherapy
timeFrame: within 3 weeks after the completion of the treatment
Secondary outcomes:
measure: Overall survival, response duration, toxicity profiles
timeFrame: up to 5 years after the completion of treatment
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center, Korea
Study officials:
affiliation: National Cancer Center, Korea
name: Hyeon Seok Eom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Won YW, Lee H, Eom HS, Kim JS, Suh C, Yoon DH, Hong JY, Kang HJ, Lee JH, Kim WS, Kim SJ, Lee WS, Chang MH, Do YR, Yi JH, Kim I, Won JH, Kim K, Oh SY, Jo JC. A phase II study of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma. Ann Hematol. 2020 Feb;99(2):255-264. doi: 10.1007/s00277-019-03891-9. Epub 2020 Jan 2.