Primary Non Hodgkin Lymphoma of the Central Nervous SystemPhase 2PRIMAINNCT00989352
Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
A Phase 2 study testing Methotrexate, Lomustine and Procarbazine in people with Primary Non Hodgkin Lymphoma of the Central Nervous System, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Primary Non Hodgkin Lymphoma of the Central Nervous System
- What is being tested?
- Methotrexate, Lomustine and Procarbazine
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Sep 2011
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- first diagnosis of PCNSL, histologically confirmed
- age > 65 years
- written signed and dated informed consent of the legal representative and - if possible - of the patient
Who cannot join
- manifestations of further lymphoma outside the CNS
- sero-positive for HIV
- severe pulmonary, cardiac, hepatic, renal impairment
- uncontrolled infection
- neutrophil count < 1.500/µl, platelet count < 100.000/µl
- pulmonary disease with IVC < 55%, DLCO < 40%
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- cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
- creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
- bilirubin > 2mg/dl
- ascites or pleural effusion (> 500ml)
- known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
- participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
- known or current drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Freiburg im Breisgau, 79106
Gerald Illerhaus, PD Dr., +497612703785, Gerald.Illerhaus@uniklinik-freiburg.de
Elvira Burger, +497612707378, elvira.burger@uniklinik-freiburg.de
About this study
Official title: Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy
The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years.
- Being tested
- Methotrexate, Lomustine, Procarbazine, Rituximab
- Keywords
- PCNSL, Lymphoma, Methotrexate, Lomustine, Procarbazine, Rituximab, Elderly, Chemotherapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
3g/m² i.v. max. 9 times
LomustineDrug
110 mg/m² p.o., max. 3 times
ProcarbazineDrug
60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times
RituximabDrug
375 mg/m² i.v., max. 10 times
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
Measured: 30 days after end of immuno-chemotherapy
Secondary outcomes (4)
Duration of response
Measured: within 5 years
Overall survival time
Measured: within 5 years
Neuropsychological state (according to Mini-Mental State and IPCG testing)
Measured: within 5 years
(Serious) adverse events ([S]AEs)
Measured: within 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Non Hodgkin Lymphoma of the Central Nervous SystemStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Köln, LMU Klinikum, University Hospital Heidelberg, University Hospital Ulm
- Investigators
- Gerald Illerhaus, PD Dr., Principal investigator, University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989352
- Sponsor's protocol ID
- 00591
- Other IDs
- Eudract: 2008-007645-31
- Acronym
- PRIMAIN
- Status last verified
- Oct 2009
- First submitted
- 2 Oct 2009
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Illerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26.
PubMed 18953065Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15.
PubMed 27843136
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy
- ClinicalTrials.gov ID
- NCT00989352
- Acronym / sponsor ID
- PRIMAIN / 00591
- Keywords
- PCNSL, Lymphoma, Methotrexate, Lomustine, Procarbazine, Rituximab, Elderly, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Universitätsklinikum Köln, LMU Klinikum, University Hospital Heidelberg, University Hospital Ulm
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 5 Oct 2009 (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 determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- first diagnosis of PCNSL, histologically confirmed
- age > 65 years
- written signed and dated informed consent of the legal representative and - if possible - of the patient
Key exclusion criteria (13 listed)
- manifestations of further lymphoma outside the CNS
- sero-positive for HIV
- severe pulmonary, cardiac, hepatic, renal impairment
- uncontrolled infection
- neutrophil count < 1.500/µl, platelet count < 100.000/µl
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 |
|---|---|---|
| Methotrexate3g/m² i.v. max. 9 times | Drug | – |
| Lomustine110 mg/m² p.o., max. 3 times | Drug | – |
| Procarbazine60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times | Drug | – |
| Rituximab375 mg/m² i.v., max. 10 times | Drug | – |
Primary outcome
Complete remission rate
Time frame: 30 days after end of immuno-chemotherapy
4 secondary outcomes
Duration of response
Time frame: within 5 years
Overall survival time
Time frame: within 5 years
Neuropsychological state (according to Mini-Mental State and IPCG testing)
Time frame: within 5 years
(Serious) adverse events ([S]AEs)
Time frame: within 30 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2009.
- Background: PubMed 18953065Illerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26.
- Derived from this study: PubMed 27843136Fritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15.
- Related InfoLink provided by the sponsor.
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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.
Gerald Illerhaus, PD Dr. principal investigator
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
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 Methotrexate, Lomustine and Procarbazine in people with Primary Non Hodgkin Lymphoma of the Central Nervous System, run by University Hospital Freiburg at 1 site in Germany.
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 3 inclusion and 13 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 5 Oct 2009. 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 Germany. 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 Gerald Illerhaus, PD Dr. (+497612703785, Gerald.Illerhaus@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: 30 days after end of immuno-chemotherapy). 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 NCT00989352, which also lists 2 linked publications.
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 5 Oct 2009.