Central Nervous System LymphomaPhase 2NCT01458730
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
A Phase 2 study testing Immunochemotherapy in people with Central Nervous System Lymphoma, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Nervous System Lymphoma
- What is being tested?
- Immunochemotherapy
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- May 2007to Aug 2022
- 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
- Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
- Patients treated with steroids alone are eligible
- No signs of lymphoma outside the CNS
- ECOG performance status 0-4
- Age > 17 and < 76 years
- Written informed consent from the patient or guardian
Who cannot join
- Cardiac failure > 3
- Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
- Previous malignancy unless disease free for at least five years
- Active infection.
- Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
- Positive HIV status
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- Organ transplantation
- Serious psychiatric illness
- Prior radiotherapy to the brain
- Concomitant anti-inflammatory medication that cannot be discontinued
- Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
- Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
- Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal.
- Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide.
The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.
Read the detailed description
The objective of the study is
- To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
- To assess the long term outcome concerning neurotoxicity
- Conditions
- Central Nervous System Lymphoma
- Being tested
- Immunochemotherapy
- Keywords
- PCNSL, Immunochemotherapy, Intraspinal Depocyt, Maintenance temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunochemotherapyDrug
Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (2)
response rate
Measured: at completion of therapy
neurotoxicity
Measured: 1-10 years after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startMay 2007
- Primary completionOct 2010
- Study completionAug 2022
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 Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Cancer Union, Roche Pharma AG, Mundipharma Pte Ltd., Schering-Plough
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458730
- Sponsor's protocol ID
- EudraCT No 2006-004772-12
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2011
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Pulczynski EJ, Kuittinen O, Erlanson M, Hagberg H, Fossa A, Eriksson M, Nordstrom M, Ostenstad B, Fluge O, Leppa S, Fiirgaard B, Bersvendsen H, Fagerli UM. Successful change of treatment strategy in elderly patients with primary central nervous system lymphoma by de-escalating induction and introducing temozolomide maintenance: results from a phase II study by the Nordic Lymphoma Group. Haematologica. 2015 Apr;100(4):534-40. doi: 10.3324/haematol.2014.108472. Epub 2014 Dec 5.
PubMed 25480497
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide.
- ClinicalTrials.gov ID
- NCT01458730
- Acronym / sponsor ID
- EudraCT No 2006-004772-12
- Conditions
- Central Nervous System Lymphoma
- Keywords
- PCNSL, Immunochemotherapy, Intraspinal Depocyt, Maintenance temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Nordic Cancer Union, Roche Pharma AG, Mundipharma Pte Ltd., Schering-Plough
- Study start
- May 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 25 Oct 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 the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.
Detailed description
The objective of the study is
- To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
- To assess the long term outcome concerning neurotoxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
- Patients treated with steroids alone are eligible
- No signs of lymphoma outside the CNS
- ECOG performance status 0-4
- Age > 17 and < 76 years
Key exclusion criteria (14 listed)
- Cardiac failure > 3
- Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
- Previous malignancy unless disease free for at least five years
- Active infection.
- Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
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 |
|---|---|---|
| ImmunochemotherapyRituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte | Drug | – |
Primary outcome
Overall survival
2 secondary outcomes
response rate
Time frame: at completion of therapy
neurotoxicity
Time frame: 1-10 years after completion of therapy
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 4 Aug 2022.
- Derived from this study: PubMed 25480497Pulczynski EJ, Kuittinen O, Erlanson M, Hagberg H, Fossa A, Eriksson M, Nordstrom M, Ostenstad B, Fluge O, Leppa S, Fiirgaard B, Bersvendsen H, Fagerli UM. Successful change of treatment strategy in elderly patients with primary central nervous system lymphoma by de-escalating induction and introducing temozolomide maintenance: results from a phase II study by the Nordic Lymphoma Group. Haematologica. 2015 Apr;100(4):534-40. doi: 10.3324/haematol.2014.108472. Epub 2014 Dec 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immunochemotherapy in people with Central Nervous System Lymphoma, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 14 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 4 Aug 2022. 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 Denmark. 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?
Overall survival. 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 NCT01458730, 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 4 Aug 2022; AzTrials last refreshed its copy on 3 Nov 2026.