Clinical trial · Interventional
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
NCT02399189CI-TRIAL-00017482unknownPhase 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 evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma.
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 Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-MT followed by auto-HSCT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-MT followed by auto-HSCT
- description
- R-MT followed by auto-HSCT Rituximab 375 mg/m2 d1 MTX 3.5g/m2 d2(0.5g/m2 15min,3g/m2 3h） TMZ 100 mg/m2 d2-6 Q21d\*4cycles Auto-HSCT conditioning regimen: BCNU 400mg/m2 d1; Thiotepa 5mg/kg q12h，d2-3
- interventionNames
- Drug: R-MT followed by auto-HSCT
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- overall response rate
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy * ECOG 0-2 * Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan * Leucocytes\>3.500/mm3, platelets\>130.000/mm3, Bilirubin \< 2 mg, transaminases \< 2.5 N), creatinine \< 150 μM/l, creatinine clearance \> 50 ml/min/1.73m2 * Age 18-65 years * Negative HIV test * Signature of informed consent Exclusion Criteria: * prior chemotherapy for primary central nervous system lymphoma * presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ ) * systemic lymphoma (outside the CNS) * Isolated ocular lymphoma * Immunosuppressed patients (HIV , use of immunosuppressors) * Other uncontrolled or progressive disease compromising shot-term survival * Severe renal or hepatic disease * Patients not legally covered by the French Social Security * Inability to swallow the medication
References
Publications (1)
- RESULTCorrea DD, Maron L, Harder H, Klein M, Armstrong CL, Calabrese P, Bromberg JE, Abrey LE, Batchelor TT, Schiff D. Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol. 2007 Jul;18(7):1145-51. doi: 10.1093/annonc/mdl464. Epub 2007 Feb 6. PMID 17284616