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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hodgkin's Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ESHAOx arm

Patients who are planned to be treated with ESHAOx chemotherapy

Group Type EXPERIMENTAL

Oxaliplatin-based chemotherapy (ESHAOx)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxaliplatin-based chemotherapy (ESHAOx)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asan Medical Center

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Natioinal Cancer Center, Korea

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyeon Seok Eom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Center, Korea

Goyang, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hyewon Lee, MD

Role: CONTACT

+82-31-920-1765

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hyewon Lee, MD

Role: primary

+82-31-920-1765

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31897676 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCCCTS-10-524

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.