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

This study is currently recruiting participants.

Verified February 2011 by National Cancer Center, Korea

Sponsor:

Collaborators:

Asan Medical Center

Severance Hospital

Information provided by:

National Cancer Center, Korea

ClinicalTrials.gov Identifier:

NCT01300156

First received: February 18, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 18, 2011

Last Updated Date

February 18, 2011

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall Response rate to ESHAOx chemotherapy [ Time Frame: within 3 weeks after the completion of the treatment ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Overall survival, response duration, toxicity profiles [ Time Frame: up to 5 years after the completion of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hodgkin's Lymphoma

Intervention ^ICMJE

Drug: Oxaliplatin-based chemotherapy (ESHAOx)

Etoposide 40 mg/m2, D1-4
Methylprednisolone 500mg, D1-5
Cytarabine 2 g/m2, D5
Oxaliplatin 130 mg/m2, D1

Study Arm (s)

Experimental: ESHAOx arm

Patients who are planned to be treated with ESHAOx chemotherapy

Intervention: Drug: Oxaliplatin-based chemotherapy (ESHAOx)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hyewon Lee, MD

+82-31-920-1765

hwlee@ncc.re.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01300156

Other Study ID Numbers ^ICMJE

NCCCTS-10-524

Has Data Monitoring Committee

Responsible Party

Hyeon-Seok Eom / MD, PhD, Natioinal Cancer Center, Korea

Study Sponsor ^ICMJE

National Cancer Center, Korea

Collaborators ^ICMJE

Asan Medical Center
Severance Hospital

Investigators ^ICMJE

Principal Investigator:

Hyeon Seok Eom, MD, PhD

National Cancer Center, Korea

Information Provided By

National Cancer Center, Korea

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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