Clinical trial · Interventional
High-dose Chemotherapy and ASCT or Consolidating Conventional Chemotherapy in Primary CNS Lymphoma
High-dose Chemotherapy and Autologous Stem Cell Transplant or Consolidating Conventional Chemotherapy in Primary CNS Lymphoma - Randomized Phase III Trial
NCT02531841CI-TRIAL-00018928MATRixunknownPhase 3ClinicalTrials.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)
In the presently planned multicentre Phase III trial the two therapies will be compared: Patients will be randomized after intensified induction treatment with 4 cycles rituximab, methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy against conventional consolidating therapy with 2 cycles of conventional chemotherapy with R-DeVIC (rituximab, dexamethasone, etoposide, ifosfamide, carboplatin).
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 |
|---|---|---|---|
| Diffuse Large B-cell-lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm A (Fortecortin®-ETOPOPHOS®-IFO-cell®-CARBO-cell®) | Drug | — | UNRESOLVED |
| Arm B (TEPADINA®-CARMUBRIS®-Busilvex®) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Induction Treatment 4 cycles MATRix (every 3 weeks), stem-cell harvest after 2nd cycle: * Rituximab 375 mg/m²/d i.v. (d0,5) * Methotrexate 3.5 g/m² i.v. (d1) * Cytarabine 2 x 2 g/m²/d i.v. (d2-3) * Thiotepa 30 mg/m² i.v. (d4) Consolidation Treatment 2 cycles of R-DeVIC (every 3 weeks): * Rituximab 375 mg/m²/d i.v. (d0) * Dexamethasone 40 mg/d i.v. (d1-3) * Etoposide 100 mg/m²/d i.v. (d1-3) * Ifosfamide 1500 mg/m²/d i.v. (d1-3) * Carboplatin 300 mg/m² i.v. (d1)
- interventionNames
- Drug: Arm A (Fortecortin®-ETOPOPHOS®-IFO-cell®-CARBO-cell®)
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Induction Treatment 4 cycles MATRix (every 3 weeks), stem-cell harvest after 2nd cycle: * Rituximab 375 mg/m²/d i.v. (d0,5) * Methotrexate 3.5 g/m² i.v. (d1) * Cytarabine 2 x 2 g/m²/d i.v. (d2-3) * Thiotepa 30 mg/m² i.v. (d4) Consolidation Treatment High-dose chemotherapy * Carmustine\* 400 mg/m² i.v. (d-6) * Thiotepa 2 x 5 mg/kg/d i.v. (d-5-(-4)) * Autologous Stem Cell Transplantation (d0) \*if not available at study site, Busulfan can be administered instead: * Busulfan 3,2 mg/kg/d i.v. (d-8-(-7)) * Thiotepa 2 x 5 mg/kg/d i.v. (d-5-(-4)) * Autologous Stem Cell Transplantation (d0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma 2. Age 18-65 years irrespective of ECOG or 66-70 years (with ECOG Performance Status ≤2) 3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist. 4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy 5. Disease exclusively located in the CNS 6. At least one measurable lesion 7. Previously untreated patients (previous or ongoing steroid treatment admitted) 8. Sexually active patients of childbearing potential who agree to take adequate contraceptive measures during study participation 9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease ADDITIONAL RANDOMIZATION CRITERIA 1. Sufficient stem cell harvest (≥ 5 x 106 CD34+ cells/kg of body weight) 2. Complete remission, unconfirmed complete remission or partial remission 3. Central pathology results confirming local results Exclusion Criteria: 1. Congenital or acquired immunodeficiency 2. Systemic lymphoma manifestation (outside the CNS) 3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord 4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years 5. Previous Non-Hodgkin lymphoma at any time 6. Inadequate bone marrow (platelet count decreased ≥CTC grade 1, anemia ≥CTC grade 1, neutrophil count decreased ≥CTC grade 1), renal (creatinine clearance \<60 ml/min), cardiac (ejection fraction decreased ≥CTC grade 2), or hepatic function (blood bilirubin increased ≥CTC grade 2, alanine aminotransferase increased ≥CTC grade 2, aspartate aminotransferase increased ≥CTC grade 2 or gamma-GT increased ≥CTC grade 2) 7. HBsAg, anti-HBc or HCV positivity 8. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency 9. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study 10. Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease) 11. Severe non-compensated pulmonary disease (IVC \<55%, DLCO \<40%) 12. Third space fluid accumulation \>500 ml 13. Hypersensitivity to study treatment or any component of the formulation 14. Taking any medications likely to cause interactions with the study medication 15. Known or persistent abuse of medication, drugs or alcohol 16. Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative 17. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator 18. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 19. Concurrent (or planned) pregnancy or lactation 20. Fertile patients refusing to use safe contraceptive methods during the study
References
Publications (7)
- RESULTIllerhaus 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
- RESULTIllerhaus G, Muller F, Feuerhake F, Schafer AO, Ostertag C, Finke J. High-dose chemotherapy and autologous stem-cell transplantation without consolidating radiotherapy as first-line treatment for primary lymphoma of the central nervous system. Haematologica. 2008 Jan;93(1):147-8. doi: 10.3324/haematol.11771. PMID 18166803
- RESULTKasenda B, Schorb E, Fritsch K, Finke J, Illerhaus G. Prognosis after high-dose chemotherapy followed by autologous stem-cell transplantation as first-line treatment in primary CNS lymphoma--a long-term follow-up study. Ann Oncol. 2012 Oct;23(10):2670-2675. doi: 10.1093/annonc/mds059. Epub 2012 Apr 3. PMID 22473593
- RESULTSoussain C, Hoang-Xuan K, Taillandier L, Fourme E, Choquet S, Witz F, Casasnovas O, Dupriez B, Souleau B, Taksin AL, Gisselbrecht C, Jaccard A, Omuro A, Sanson M, Janvier M, Kolb B, Zini JM, Leblond V; Societe Francaise de Greffe de Moelle Osseuse-Therapie Cellulaire. Intensive chemotherapy followed by hematopoietic stem-cell rescue for refractory and recurrent primary CNS and intraocular lymphoma: Societe Francaise de Greffe de Moelle Osseuse-Therapie Cellulaire. J Clin Oncol. 2008 May 20;26(15):2512-8. doi: 10.1200/JCO.2007.13.5533. Epub 2008 Apr 14. PMID 18413641
- RESULTMotomura K, Natsume A, Fujii M, Ito M, Momota H, Wakabayashi T. Long-term survival in patients with newly diagnosed primary central nervous system lymphoma treated with dexamethasone, etoposide, ifosfamide and carboplatin chemotherapy and whole-brain radiation therapy. Leuk Lymphoma. 2011 Nov;52(11):2069-75. doi: 10.3109/10428194.2011.596967. Epub 2011 Jul 12. PMID 21745167
- Illerhaus G, Ferreri AJM, Wendler J, Binder M, Borchmann P, Hasenkamp J, Stilgenbauer S, Roth A, Egerer G, Ernst T, Weber T, Hertenstein B, Lenz G, Dreyling M, Mohle R, Kobbe G, Schmidt CA, Brunnberg U, Panse J, Kneba M, Heinicke T, Schroll S, Larsen TS, Thurner L, Pukrop T, Salwender H, Naumann R, Hess G, Kroschinsky FP, Blystad AK, Keller U, Pulczynski EJ, Pedersen MB, Re F, Orsucci L, Pospiech L, La Rosee P, Deckert M, Ponzoni M, Gmehlin D, Backenstrass M, Jensch A, Valk E, Calimeri T, Kasenda B, Trepel M, Fricker H, Semenova I, Scherer F, von Gottberg P, Burger E, Grishina O, Hader C, Ihorst G, Finke J, Zucca E, Schorb E. High-dose chemotherapy followed by autologous stem-cell transplantation versus non-myeloablative consolidation in primary CNS lymphoma (MATRix/IELSG43): a randomised phase 3 trial. Lancet. 2026 Aug 8;408(10554):532-544. doi: 10.1016/S0140-6736(26)00917-7. Epub 2026 Jul 22.