Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
PRIMAIN
Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy
2 other identifiers
interventional
56
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 5, 2009
October 1, 2009
1.7 years
October 2, 2009
October 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete remission rate
30 days after end of immuno-chemotherapy
Secondary Outcomes (4)
Duration of response
within 5 years
Overall survival time
within 5 years
Neuropsychological state (according to Mini-Mental State and IPCG testing)
within 5 years
(Serious) adverse events ([S]AEs)
within 30 days after treatment
Interventions
3g/m² i.v. max. 9 times
110 mg/m² p.o., max. 3 times
60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times
375 mg/m² i.v., max. 10 times
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Freiburglead
- Universitätsklinikum Kölncollaborator
- Ludwig-Maximilians - University of Munichcollaborator
- University Hospital Heidelbergcollaborator
- University Hospital Ulmcollaborator
Study Sites (1)
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Freiburg im Breisgau, 79106, Germany
Related Publications (2)
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.
PMID: 18953065BACKGROUNDFritsch 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.
PMID: 27843136DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald Illerhaus, PD Dr.
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 5, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2011
Study Completion
September 1, 2011
Last Updated
October 5, 2009
Record last verified: 2009-10