Health Condition 1: C833- Diffuse large B-cell lymphoma
Conditions
Interventions
Intervention1: Whole-Brain Radiotherapy (WBRT) and Lenalidomide: Primary Central Nervous System Lymphoma (PCNSL) is a rare, high-grade subtype of non-Hodgkin s lymphoma (NHL) limited to the brain, spi
Sponsors
Indian Council of Medical Research
TRAC Intramural Grant
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients should have either biopsy-proven or radiological suspected PCNSL where biopsy is not feasible 2. Diagnosed cases of PCNSL who are ineligible for induction chemotherapy. 3. PCNSL post-induction PR not feasible for consolidation CT or ASCT 4.Diagnosed cases of PCNSL who are ineligible for consolidation Chemotherapy. 5.Diagnosed case of PCNSL, post-consolidation Chemotherapy who has PR, PD, SD 6.Relapsed PCNSL post-CNS-directed therapy for primary disease. -Where systemic Chemotherapy is not feasible 7. ECOG 3/4(because of disease.) 8. Age greater than 18yrs 9. Should have at least MRI Brain Pre-RT. 10. Eligible to take lenalidomide maintenance
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with PCNSL who attained complete response after consolidation therapy. 2.ECOG 3 or more and unrelated to PCNSL. 3.Adequate bone marrow function with absolute leukocytes greater than 3000/mm3, neutrophil count (ANC) greater than 1500/mm3, hemoglobin greater than 10 g/dl and platelets greater than 100 000/mm3 4. Adequate liver function with Serum SGOT or AST or SGPT or ALT less than 3.0 X Upper Limit of Normal ULN; bilirubin less than 1.5 X LNS 5. Creatinine clearance greater than 60 ml/min. Patients with calculated creatinine clearance less than 60 will be treated with pomalidomide. 6. Able to DVT prophylaxis 7. Able to understand the teratogenicity 8. Men and women of childbearing age should agree to use reliable contraception 9. Neuropathy of less than or equal to grade 2 severity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective(s): 1. To evaluate the 2-year progression-free survival in patients treated with WBRT and maintenance lenalidomide. Timepoint: Primary Endpoint: Progression-free survival at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): 1. To evaluate therapy response (Overall Response rate ORR, CR & PR) 2. To evaluate 2-year overall survival. 3.Evaluation ofNeuro-cognition- As per IPCG Neurocognitive Battery Timepoint: Secondary Endpoint(s): 1. Overall survival at 2 years. 2. Evaluate the Overall Response rate and CR rates at 3 months post therapy 3. Evaluation of Neurocognitive functions time points: Pre WBRT,6 months after WBRT,1 year & 2 years after WBRT | — |
Countries
India
Contacts
Public ContactDR JAYANT SASTRI GODA
The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed