Clinical trial · Interventional
Freiburg ZNS-NHL Study
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
NCT00647049CI-TRIAL-00002778unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \[PCNSL\].
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Non Hodgkin Lymphoma of the Central Nervous System | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustin | Drug | Carmustine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- first diagnosis of PCNSL: combined chemotherapy with methotrexate
- interventionNames
- Drug: methotrexate
- Drug: Rituximab
- Drug: Cytarabine
- Drug: Thiotepa
- Drug: Carmustin
- type
- EXPERIMENTAL
- label
- B
- description
- Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
- interventionNames
- Drug: Rituximab
- Drug: Cytarabine
- Drug: Thiotepa
- Drug: Carmustin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
References
Publications (3)
- BACKGROUNDIllerhaus 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. PMID 16864853
- DERIVEDKasenda 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. PMID 28559537
- DERIVEDIllerhaus 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. PMID 27476790