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

Primary Purpose

Hodgkin's Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxaliplatin-based chemotherapy (ESHAOx)
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's disease, lymphoma, Relapsed, refractory

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cancer Center, KoreaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ESHAOx arm

Arm Description

Patients who are planned to be treated with ESHAOx chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival, response duration, toxicity profiles

Full Information

First Posted
February 18, 2011
Last Updated
February 18, 2011
Sponsor
National Cancer Center, Korea
Collaborators
Asan Medical Center, Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01300156
Brief Title
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

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea
Collaborators
Asan Medical Center, Severance Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
Keywords
Hodgkin's disease, lymphoma, Relapsed, refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESHAOx arm
Arm Type
Experimental
Arm Description
Patients who are planned to be treated with ESHAOx chemotherapy
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin-based chemotherapy (ESHAOx)
Intervention Description
Etoposide 40 mg/m2, D1-4 Methylprednisolone 500mg, D1-5 Cytarabine 2 g/m2, D5 Oxaliplatin 130 mg/m2, D1
Primary Outcome Measure Information:
Title
Overall Response rate to ESHAOx chemotherapy
Description
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.
Time Frame
within 3 weeks after the completion of the treatment
Secondary Outcome Measure Information:
Title
Overall survival, response duration, toxicity profiles
Time Frame
up to 5 years after the completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyewon Lee, MD
Phone
+82-31-920-1765
Email
hwlee@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon Seok Eom, MD, PhD
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyewon Lee, MD
Phone
+82-31-920-1765
Email
hwlee@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Hyeon Seok Eom, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31897676
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.
Results Reference
derived

Learn more about this trial

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

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