Clinical trial · Interventional
High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas
Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas
NCT01148173CI-TRIAL-00003592unknownPhase 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)
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.
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 |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined systemic and intrathecal chemotherapy followed by HD-ASCT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Systemic and intrathecal chemotherapy
- interventionNames
- Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT
Primary outcomes (1)
- measure
- Time to treatment failure
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- 2 years
- measure
- Remission rate
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3° * CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations * ECOG performance score ≤2 * no active infection * negative HIV-serology * adequate renal function (creatinine clearance \> 50 ml/min) * adequate bone marrow function (granulocytes \>1500/μl, platelets \> 80000/μl) * normal bilirubin, AST \< 3 x UNL * negative pregnancy test Exclusion Criteria: * newly diagnosed NHL with primary CNS involvement * indolent NHL, lymphoblastic NHL or Burkitt lymphoma * preceding CNS irradiation * pretreatment of CNS relapse other than corticosteroids * immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation * second cancer other than basalioma or cervical carcinoma in situ within the last 5 years * unfit to receive an intensive chemotherapy * pregnancy or breastfeeding * known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide
References
Publications (1)
- DERIVEDKorfel A, Elter T, Thiel E, Hanel M, Mohle R, Schroers R, Reiser M, Dreyling M, Eucker J, Scholz C, Metzner B, Roth A, Birkmann J, Schlegel U, Martus P, Illerhaus G, Fischer L. Phase II study of central nervous system (CNS)-directed chemotherapy including high-dose chemotherapy with autologous stem cell transplantation for CNS relapse of aggressive lymphomas. Haematologica. 2013 Mar;98(3):364-70. doi: 10.3324/haematol.2012.077917. Epub 2012 Dec 14. PMID 23242601