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Disease outcomes and effect of treatment on brain function in patients with primary CNS Lymphoma undergoing high dose chemotherapy.

Prospective evaluation of patients with primary CNS Lymphoma undergoing high dose consolidation chemotherapy with LACE.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/030005
Enrollment
25
Registered
2020-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C851- Unspecified B-cell lymphoma

Interventions

Intervention1: High dose chemotherapy with LACE regimen: Lomustine ( 200 mg/m2 ) D-7 Etoposide ( 1000 mg/m2 ) D-7 Cytosar ( 2000 mg/m2) D-6, D-5 Cyclophosphamide (1800mg/m2)D-4, D-3, D-2

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven PCNSL and planned for ASCT 2. Age > 18 years and less than 65 years 3. ECOG PS 4. Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count (ANC) > 1000/mm3, hemoglobin > 8 g/dl and platelets > 100 000/mm3 5. Adequate liver function with Serum SGOT/AST or SGPT/ALT 6. Creatinine clearance > 60 ml/min. 7. Adequate cardiac function (LVEF more than 45%) 8. Adequate lung function (DLCO more than 50%) 9. Able to understand and sign informed consent

Exclusion criteria

Exclusion criteria: Chemo-refractory disease 2. HIV infection 3. Active hepatitis B or C 4. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

Design outcomes

Primary

MeasureTime frame
Progression Free SurvivalTimepoint: 2 years

Secondary

MeasureTime frame
Grade 3 or more side effects Timepoint: 2 years;Neuro-cognitive assessmentTimepoint: 2 years;Overall survivalTimepoint: 2 year;Quality of lifeTimepoint: 2 years

Countries

India

Contacts

Public ContactDr Navin Khattry

Tata Memorial Centre - ACTREC

nkhattry@gmail.com02227405000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026