Hodgkin's LymphomaPhase 2NCT01300156
Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)
A Phase 2 study testing Oxaliplatin-based chemotherapy (ESHAOx) in people with Hodgkin's Lymphoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Oxaliplatin-based chemotherapy (ESHAOx)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center, Korea
Goyang
Hyewon Lee, MD, +82-31-920-1765, hwlee@ncc.re.kr
Hyeon Seok Eom, MD, PhD
About this study
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)
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).
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Oxaliplatin-based chemotherapy (ESHAOx)
- Keywords
- Hodgkin's disease, lymphoma, Relapsed, refractory
- Medical subject headings
- Hodgkin Disease, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ESHAOx arm | Experimental | Patients who are planned to be treated with ESHAOx chemotherapy Receives: Drug: Oxaliplatin-based chemotherapy (ESHAOx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 weeks after the completion of the treatment
Secondary outcomes (1)
Overall survival, response duration, toxicity profiles
Measured: up to 5 years after the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Asan Medical Center, Severance Hospital
- Investigators
- Hyeon Seok Eom, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300156
- Sponsor's protocol ID
- NCCCTS-10-524
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31897676
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01300156
- Acronym / sponsor ID
- NCCCTS-10-524
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin's disease, lymphoma, Relapsed, refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Asan Medical Center, Severance Hospital
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESHAOx arm | Experimental | Drug: Oxaliplatin-based chemotherapy (ESHAOx)Patients who are planned to be treated with ESHAOx chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxaliplatin-based chemotherapy (ESHAOx)* Etoposide 40 mg/m2, D1-4 * Methylprednisolone 500mg, D1-5 * Cytarabine 2 g/m2, D5 * Oxaliplatin 130 mg/m2, D1 | Drug | ESHAOx arm |
Primary outcome
Overall Response rate to ESHAOx chemotherapy
Time frame: within 3 weeks after the completion of the treatment
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.
1 secondary outcome
Overall survival, response duration, toxicity profiles
Time frame: up to 5 years after the completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
- Derived from this study: PubMed 31897676Won 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeon Seok Eom, MD, PhD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin-based chemotherapy (ESHAOx) in people with Hodgkin's Lymphoma, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyewon Lee, MD (+82-31-920-1765, hwlee@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response rate to ESHAOx chemotherapy (time frame: within 3 weeks after the completion of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01300156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.