Primary Non Hodgkin Lymphoma of the Central Nervous SystemPhase 2NCT00647049
Freiburg ZNS-NHL Study
A Phase 2 study testing methotrexate, Rituximab and Cytarabine 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 (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Non Hodgkin Lymphoma of the Central Nervous System
- What is being tested?
- methotrexate, Rituximab and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Aug 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- group A: first diagnosis of PCNSL, histologically confirmed
- group B: relapse or progression of PCNSL after MTX containing chemotherapy
- age 18 - 65 years
- not legally incompetent, physically or mentally incapable of giving consent
- 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
- neutrophil count < 2.000/µl, platelet count < 100.000/µl
- pulmonary disease with IVC < 55%, DLCO < 40%
- cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
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- creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
- bilirubin > 2mg/dl
- ascites or pleural effusion (> 500ml)
- pregnancy o r lactation
- women with childbearing potential without sufficient contraception
- 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
- known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Freiburg
Freiburg im Breisgau, 79106
Gerald Illerhaus, Dr., 00497612703785, Gerald.Illerhaus@uniklinik-freiburg.de
Andreas Zähringer, 00497612707378, andreas.zaehringer@uniklinik-freiburg.de
About this study
Official title: Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation
The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].
- Being tested
- methotrexate, Rituximab, Cytarabine, Thiotepa, Carmustin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
Also called MTX
8000mg/m2 i.v., max. 2 cycles
RituximabDrug
375mg/m2, max. 8 times
CytarabineDrug
Also called Arabinoside
3000mg/m2 die i.v., 2 days (max. 2 cycles)
ThiotepaDrug
40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
CarmustinDrug
Also called BCNU, Bis-Chlorethyl-Nitrosourea
400mg/m2 i.v. for 1 day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | first diagnosis of PCNSL: combined chemotherapy with methotrexate Receives: Drug: methotrexate; Drug: Rituximab; Drug: Cytarabine; Drug: Thiotepa; Drug: Carmustin |
| B | Experimental | Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy Receives: Drug: Rituximab; Drug: Cytarabine; Drug: Thiotepa; Drug: Carmustin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: 30 days after blood stem cell transplantation
Secondary outcomes (5)
Duration of response
Measured: within 5 years
Overall survival time
Measured: within 5 years
Neuropsychological state according to Mini-Mental State
Measured: within 5 years
Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20)
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 posted31 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Investigators
- Jürgen Finke, Prof. Dr., Principal investigator, University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647049
- Sponsor's protocol ID
- ZNS-00465
- Status last verified
- Nov 2009
- First submitted
- 26 Mar 2008
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Illerhaus G, Marks R, Ihorst G, Guttenberger R, Ostertag C, Derigs G, Frickhofen N, Feuerhake F, Volk B, Finke J. High-dose chemotherapy with autologous stem-cell transplantation and hyperfractionated radiotherapy as first-line treatment of primary CNS lymphoma. J Clin Oncol. 2006 Aug 20;24(24):3865-70. doi: 10.1200/JCO.2006.06.2117. Epub 2006 Jul 24.
PubMed 16864853Kasenda B, Ihorst G, Schroers R, Korfel A, Schmidt-Wolf I, Egerer G, von Baumgarten L, Roth A, Bloehdorn J, Mohle R, Binder M, Keller U, Lamprecht M, Pfreundschuh M, Valk E, Fricker H, Schorb E, Fritsch K, Finke J, Illerhaus G. High-dose chemotherapy with autologous haematopoietic stem cell support for relapsed or refractory primary CNS lymphoma: a prospective multicentre trial by the German Cooperative PCNSL study group. Leukemia. 2017 Dec;31(12):2623-2629. doi: 10.1038/leu.2017.170. Epub 2017 May 31.
PubMed 28559537Illerhaus G, Kasenda B, Ihorst G, Egerer G, Lamprecht M, Keller U, Wolf HH, Hirt C, Stilgenbauer S, Binder M, Hau P, Edinger M, Frickhofen N, Bentz M, Mohle R, Roth A, Pfreundschuh M, von Baumgarten L, Deckert M, Hader C, Fricker H, Valk E, Schorb E, Fritsch K, Finke J. High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. Lancet Haematol. 2016 Aug;3(8):e388-97. doi: 10.1016/S2352-3026(16)30050-3. Epub 2016 Jul 13.
PubMed 27476790
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation
- ClinicalTrials.gov ID
- NCT00647049
- Acronym / sponsor ID
- ZNS-00465
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Jan 2007
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 31 Mar 2008 (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 (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: methotrexate, Drug: Rituximab, Drug: Cytarabine, Drug: Thiotepa, Drug: Carmustinfirst diagnosis of PCNSL: combined chemotherapy with methotrexate |
| B | Experimental | Drug: Rituximab, Drug: Cytarabine, Drug: Thiotepa, Drug: CarmustinPatients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- group A: first diagnosis of PCNSL, histologically confirmed
- group B: relapse or progression of PCNSL after MTX containing chemotherapy
- age 18 - 65 years
- not legally incompetent, physically or mentally incapable of giving consent
- written signed and dated informed consent of the legal representative and - if possible - of the patient
Key exclusion criteria (14 listed)
- manifestations of further lymphoma outside the CNS
- sero-positive for HIV
- severe pulmonary, cardiac, hepatic, renal impairment
- neutrophil count < 2.000/µl, platelet count < 100.000/µl
- pulmonary disease with IVC < 55%, DLCO < 40%
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 |
|---|---|---|
| methotrexateAlso: MTX8000mg/m2 i.v., max. 2 cycles | Drug | A |
| Rituximab375mg/m2, max. 8 times | Drug | A, B |
| CytarabineAlso: Arabinoside3000mg/m2 die i.v., 2 days (max. 2 cycles) | Drug | A, B |
| Thiotepa40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days | Drug | A, B |
| CarmustinAlso: BCNU, Bis-Chlorethyl-Nitrosourea400mg/m2 i.v. for 1 day | Drug | A, B |
Primary outcome
Complete response rate
Time frame: 30 days after blood stem cell transplantation
5 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
Time frame: within 5 years
Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20)
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 17 Nov 2009.
- Background: PubMed 16864853Illerhaus G, Marks R, Ihorst G, Guttenberger R, Ostertag C, Derigs G, Frickhofen N, Feuerhake F, Volk B, Finke J. High-dose chemotherapy with autologous stem-cell transplantation and hyperfractionated radiotherapy as first-line treatment of primary CNS lymphoma. J Clin Oncol. 2006 Aug 20;24(24):3865-70. doi: 10.1200/JCO.2006.06.2117. Epub 2006 Jul 24.
- Derived from this study: PubMed 28559537Kasenda B, Ihorst G, Schroers R, Korfel A, Schmidt-Wolf I, Egerer G, von Baumgarten L, Roth A, Bloehdorn J, Mohle R, Binder M, Keller U, Lamprecht M, Pfreundschuh M, Valk E, Fricker H, Schorb E, Fritsch K, Finke J, Illerhaus G. High-dose chemotherapy with autologous haematopoietic stem cell support for relapsed or refractory primary CNS lymphoma: a prospective multicentre trial by the German Cooperative PCNSL study group. Leukemia. 2017 Dec;31(12):2623-2629. doi: 10.1038/leu.2017.170. Epub 2017 May 31.
- Derived from this study: PubMed 27476790Illerhaus G, Kasenda B, Ihorst G, Egerer G, Lamprecht M, Keller U, Wolf HH, Hirt C, Stilgenbauer S, Binder M, Hau P, Edinger M, Frickhofen N, Bentz M, Mohle R, Roth A, Pfreundschuh M, von Baumgarten L, Deckert M, Hader C, Fricker H, Valk E, Schorb E, Fritsch K, Finke J. High-dose chemotherapy with autologous haemopoietic stem cell transplantation for newly diagnosed primary CNS lymphoma: a prospective, single-arm, phase 2 trial. Lancet Haematol. 2016 Aug;3(8):e388-97. doi: 10.1016/S2352-3026(16)30050-3. Epub 2016 Jul 13.
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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.
Jürgen Finke, Prof. 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, Rituximab and Cytarabine 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 5 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: status not confirmed, as of the sponsor's last update on 17 Nov 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, Dr. (00497612703785, 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 response rate (time frame: 30 days after blood stem cell transplantation). 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 NCT00647049, which also lists 3 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 17 Nov 2009.