CNS LymphomaPhase 2NCT01083342
High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study
A Phase 2 study testing MTX, MVD, VIA in people with CNS Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based combination consolidation chemotherapy Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- CNS Lymphoma
- What is being tested?
- MTX, MVD, VIA
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to May 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Primary Central Nervous System (CNS) lymphoma
- Previously untreated. Patients treated with steroid alone are eligible.
- Performance status: ECOG 0-3.
- Age; 20-70
- Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min
- Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value \& Bilirubin < 2 X upper normal value
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- Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL
- At least one cerebral mass lesion on magnetic resonance imaging (MRI) without involvement beyond the central nervous system (CNS)
- Life expectancy > 6 months
- A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
- Informed consent
Who cannot join
- Other subtypes NHL than Primary Central Nervous System (CNS) lymphoma
- Systemic involvement of Primary CNS lymphoma except leptomeningeal involvement
- Intraocular lymphoma
- HIV (+)
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
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- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurological or psychiatric disorders
- Active uncontrolled infection (viral, bacterial or fungal infection)
- Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-labeled, Multicenter Phase II Study of High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study
The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based combination consolidation chemotherapy
- Conditions
- CNS Lymphoma
- Being tested
- MTX, MVD, VIA
- Keywords
- primary CNS lymphoma, MTX: Methotrexate,Leucovorin, MVD: Methotrexate,Vincristine,Dexamethasone, VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C), Newly diagnosed primary CNS lymphoma patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX, MVD, VIADrug
MTX: Methotrexate,Leucovorin MVD: Methotrexate,Vincristine,Dexamethasone VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C)
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the complete response (CR) after chemotherapy
Measured: 24 months
Secondary outcomes (3)
To evaluate the duration of response
Measured: 24 months
To evaluate the progression-free survival, overall survival
Measured: 24 months
To evaluate the safety profiles
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- WonSeog Kim,, M.D., PhD., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083342
- Sponsor's protocol ID
- 2009-12-087
- Status last verified
- May 2012
- First submitted
- 8 Mar 2010
- Last updated
- 24 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labeled, Multicenter Phase II Study of High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study
- ClinicalTrials.gov ID
- NCT01083342
- Acronym / sponsor ID
- 2009-12-087
- Conditions
- CNS Lymphoma
- Keywords
- primary CNS lymphoma, MTX: Methotrexate,Leucovorin, MVD: Methotrexate,Vincristine,Dexamethasone, VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C), Newly diagnosed primary CNS lymphoma patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Mar 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 complete response (CR) rate after HD-MTX induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based combination consolidation chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed Primary Central Nervous System (CNS) lymphoma
- Previously untreated. Patients treated with steroid alone are eligible.
- Performance status: ECOG 0-3.
- Age; 20-70
- Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min
Key exclusion criteria (12 listed)
- Other subtypes NHL than Primary Central Nervous System (CNS) lymphoma
- Systemic involvement of Primary CNS lymphoma except leptomeningeal involvement
- Intraocular lymphoma
- HIV (+)
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
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 |
|---|---|---|
| MTX, MVD, VIAMTX: Methotrexate,Leucovorin MVD: Methotrexate,Vincristine,Dexamethasone VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C) | Drug | – |
Primary outcome
To evaluate the complete response (CR) after chemotherapy
Time frame: 24 months
3 secondary outcomes
To evaluate the duration of response
Time frame: 24 months
To evaluate the progression-free survival, overall survival
Time frame: 24 months
To evaluate the safety profiles
Time frame: 24 months
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 24 May 2012.
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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.
WonSeog Kim,, M.D., 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 MTX, MVD, VIA in people with CNS Lymphoma, 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 11 inclusion and 12 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 24 May 2012. 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?
To evaluate the complete response (CR) after chemotherapy (time frame: 24 months). 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 24 May 2012.