Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)
NCT ID: NCT01300156
Last Updated: 2011-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
37 participants
INTERVENTIONAL
2011-02-28
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ESHAOx arm
Patients who are planned to be treated with ESHAOx chemotherapy
Oxaliplatin-based chemotherapy (ESHAOx)
* Etoposide 40 mg/m2, D1-4
* Methylprednisolone 500mg, D1-5
* Cytarabine 2 g/m2, D5
* Oxaliplatin 130 mg/m2, D1
Interventions
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Oxaliplatin-based chemotherapy (ESHAOx)
* Etoposide 40 mg/m2, D1-4
* Methylprednisolone 500mg, D1-5
* Cytarabine 2 g/m2, D5
* Oxaliplatin 130 mg/m2, D1
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Severance Hospital
OTHER
National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Natioinal Cancer Center, Korea
Principal Investigators
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Hyeon Seok Eom, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center, Korea
Locations
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National Cancer Center, Korea
Goyang, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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NCCCTS-10-524
Identifier Type: -
Identifier Source: org_study_id
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