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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193973

Enrollment

Registered

2005-09-19

Start date

2001-07-31

Completion date

2013-08-31

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Central Nervous System Lymphoma

Keywords

Lymphoma, PCNSL, Primary CNS lymphoma

Brief summary

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.

Detailed description

Combined modality therapy in PCNSL has improved survival outcomes but at the cost of unacceptable rates of neurotoxicity when high dose radiotherapy is used. Idarubicin has activity in systemic lymphomas and crosses the blood brain barrier and may add to the efficacy of methotrexate. By combining these 2 drugs with moderate dose radiotherapy survival outcomes should be optimal but with lower rates of neurotoxicity. Comparison: TROG has previously performed a phase 2 study using methotrexate with high dose radiotherapy and this will allow comparison of survival and neurotoxicity rates.

Interventions

DRUGIdarubicin, Methotrexate, Filgrastim, intrathecal Ara-C

Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.

RADIATIONRadiation Therapy

Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To estimate the median and 2 year overall survival.	Estimate of survival at 2 years and at 5 years.

Secondary

Measure	Time frame
Assess acute toxicity.	Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
Assess functional indices of living in patients with PCNSL.	Analysis will be at 5 years.
To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.	Analysis at 3 years.

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026