NCT01300156

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

2.3 years

First QC Date

February 18, 2011

Last Update Submit

February 18, 2011

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's diseaselymphomaRelapsedrefractory

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 3 weeks after the completion of the treatment

Secondary Outcomes (1)

  • Overall survival, response duration, toxicity profiles

    up to 5 years after the completion of treatment

Study Arms (1)

ESHAOx arm

EXPERIMENTAL

Patients who are planned to be treated with ESHAOx chemotherapy

Drug: Oxaliplatin-based chemotherapy (ESHAOx)

Interventions

Oxaliplatin-based chemotherapy (ESHAOx)DRUG

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

ESHAOx arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center, Korea

Goyang, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31897676DERIVED

MeSH Terms

Conditions

Hodgkin DiseaseLymphomaRecurrence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hyeon Seok Eom, MD, PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyewon Lee, MD

CONTACT

+82-31-920-1765hwlee@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

KR(1)