Clinical trial · Interventional
Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
NCT00193973CI-TRIAL-00026027completedPhase 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)
Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve similar survival outcomes but with reduced neurotoxicity compared to regimens using methotrexate with high dose radiotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- To estimate the median and 2 year overall survival.
- timeFrame
- Estimate of survival at 2 years and at 5 years.
Secondary outcomes (3)
- measure
- Assess acute toxicity.
- timeFrame
- Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
- measure
- Assess functional indices of living in patients with PCNSL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven primary CNS lymphoma. * Absence of disease outside the CNS. * ECOG performance status 0-3 * Negative HIV status. * Peripheral blood counts with granulocytes \>1.5 x 109L and platelets \> 100 x 109L. Serum creatinine \<150mmol/L. Serum bilirubin \<1.5 times and AST \<2 times upper limit of normal. * Age \>18 and \<=70 years. * Patients must give written informed consent. * Corticosteroids prior to histological diagnosis are allowed. Exclusion Criteria: * Previous history of malignancy (other than non-melanomatous skin carcinoma, or carcinoma in situ of cervix completely excised). * Patients who are pregnant or lactating. * NYHA (New York State Heart Association classification) cardiac failure grade 3 * Macroscopic spinal thecal or spinal cord disease.
References
Publications (0)
Data not yet available
No reference posted for this study.