Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-TypePhase 2NCT01238159
Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
A Phase 2 study testing CCRT+MIDLE chemotherapy in people with Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
- What is being tested?
- CCRT+MIDLE chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients were required to have a biopsy-proven diagnosis of nasal ENKTL
- at least 18 years old
- Ann Arbor stage IE or IIE
- measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy greater than 12 weeks
- adequate hematologic (hemoglobin > 9.0 g/dL, absolute neutrophil count > 1,500/uL and platelets > 100,000/uL)
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- renal (serum creatinine < 1.5 mg/dL, creatinine clearance > 50 mL/min)
- hepatic (total bilirubin < 2 times of upper limit of normal and aspartate transferase < 3 times of upper limit of normal) function
- Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+,
- positive for cytotoxic molecules
- positive for EBV by in situ hybridization).
- Informed consent
Who cannot join
- prior or concomitant malignant tumors
- any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
- ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
- Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by MIDLE (Methotrexate, Ifosfamide, Dexamethasone, L-asparaginase, Etoposide) Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.
Read the detailed description
Concomitant chemo-radiotherapy:
Radiation 36-44 Gy/18-22 fractions (2 Gy/fraction) Weekly Cisplatin 30mg/m2 + N/S 100ml MIV over 30min Tri-weekly L-asparaginase 4000 IU IV (D1, 3, 5)
Rest period: 3 weeks
MIDLE chemotherapy: Repeated every 28 days for 2 cycles D1 Methotrexate 3g/m2 + D5W 500ml MIV over 6 hours D2-D3 Etoposide 100mg/m2 + D5W 500ml MIV over 90mins D2-D3 Ifosfamide 1000mg/m2 + D5W 100ml MIV over 1hr D2-D3 Mesna 300mg/m2 + D5W 100ml MIV over 15mins (-15min, 4hrs and 8hrs after ifosfamide, total 3 doses) D1-D4 Dexamethasone 40mg/d PO or IV D4, 6, 8, 14, 10 L-asparaginase 6000IU/m2 + D5W 500ml MIV over 2hours
- Being tested
- CCRT+MIDLE chemotherapy
- Keywords
- Natural killer cell, T cell, Lymphoma, Radiation, Chemotherapy
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRT+MIDLE chemotherapyRadiation
Also called Chemoradiotherapy
Patients are planned to be treated with CCRT plus MIDLE chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| CCRT+MIDLE | Experimental | Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy. Receives: Radiation: CCRT+MIDLE chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
The response criteria was based on the International Working Group Report (1999).
Measured: Within 4 weeks after the completion of planned treatment
Secondary outcomes (3)
Overall response rate
Overall response rate includes complete and partial response.
Measured: Up to 2 years
overall survival
Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause.
Measured: up to 2 years
Progression-free survival
Progression-free survival is defined as the time interval between the the date of diagnosis and the date of death with any cause or disease progression/relapse.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-TypeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Yonsei University, Seoul National University, Chonnam National University
- Responsible party
- Principal investigator, Kim, Seok Jin, Samsung Medical Center
- Investigators
- Won Seog Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238159
- Sponsor's protocol ID
- 2010-06-019
- Status last verified
- Mar 2015
- First submitted
- 8 Sep 2010
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by MIDLE (Methotrexate, Ifosfamide, Dexamethasone, L-asparaginase, Etoposide) Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01238159
- Acronym / sponsor ID
- 2010-06-019
- Keywords
- Natural killer cell, T cell, Lymphoma, Radiation, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Asan Medical Center, Yonsei University, Seoul National University, Chonnam National University
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Nov 2010 (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 of concomitant chemoradiation followed by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.
Detailed description
Concomitant chemo-radiotherapy:
Radiation 36-44 Gy/18-22 fractions (2 Gy/fraction) Weekly Cisplatin 30mg/m2 + N/S 100ml MIV over 30min Tri-weekly L-asparaginase 4000 IU IV (D1, 3, 5)
Rest period: 3 weeks
MIDLE chemotherapy: Repeated every 28 days for 2 cycles D1 Methotrexate 3g/m2 + D5W 500ml MIV over 6 hours D2-D3 Etoposide 100mg/m2 + D5W 500ml MIV over 90mins D2-D3 Ifosfamide 1000mg/m2 + D5W 100ml MIV over 1hr D2-D3 Mesna 300mg/m2 + D5W 100ml MIV over 15mins (-15min, 4hrs and 8hrs after ifosfamide, total 3 doses) D1-D4 Dexamethasone 40mg/d PO or IV D4, 6, 8, 14, 10 L-asparaginase 6000IU/m2 + D5W 500ml MIV over 2hours
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCRT+MIDLE | Experimental | Radiation: CCRT+MIDLE chemotherapyPatients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- patients were required to have a biopsy-proven diagnosis of nasal ENKTL
- at least 18 years old
- Ann Arbor stage IE or IIE
- measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy greater than 12 weeks
Key exclusion criteria (4 listed)
- prior or concomitant malignant tumors
- any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
- ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
- Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.
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 |
|---|---|---|
| CCRT+MIDLE chemotherapyAlso: ChemoradiotherapyPatients are planned to be treated with CCRT plus MIDLE chemotherapy | Radiation | CCRT+MIDLE |
Primary outcome
Complete response
Time frame: Within 4 weeks after the completion of planned treatment
The response criteria was based on the International Working Group Report (1999).
3 secondary outcomes
Overall response rate
Time frame: Up to 2 years
overall survival
Time frame: up to 2 years
Progression-free survival
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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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.
Won Seog Kim, MD, PhD principal investigator
Samsung Medical Center
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 CCRT+MIDLE chemotherapy in people with Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, run by Samsung Medical Center 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 12 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (time frame: Within 4 weeks after the completion of planned treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2015.