Health Condition 1: C833- Diffuse large B-cell lymphoma
Conditions
Interventions
Intervention1: R-CHP + polatuzumab vedotin: polatuzumab vedotin 1.8 mg/kg IV, rituximab 375 mg/m2 IV, cyclophosphamide 750 mg/m2 IV, and doxorubicin 50 mg/m2 IV each given on Day 1 and prednisone 100
Sponsors
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed written Informed Consent Form 2. IPI score of 2 to 5 3. Previously untreated patients with CD20 positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms a. DLBCL, not otherwise specified including germinal center B-cell type, activated B-cell type b. DLBCL with MYC and BCL2 rearrangements 4. ECOG Performance Status of 0, 1, or 2 5. Life expectancy more than 12 months 6. At least one bidimensionally measurable lesion, defined as more than 1.5 cm in its longest dimension as measured by CT or MRI 7. Left ventricular ejection fraction (LVEF) more than equal to 50percent on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) 8. Adequate hematologic function a. Hemoglobin more than equal to 9.0 g/dL without packed RBC transfusion during 14 days before first treatment b. ANC more than equal to 1,000 per microL c. Platelet count more than equal to 75,000 per microL 9. For men and women of childbearing potential should be in agreement to remain abstinent.
Exclusion criteria
Exclusion criteria: 1. Contraindication to any of the individual components of RCHP, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products. 2. Prior organ transplantation 3. Current Grade more than 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease 4. History of indolent lymphoma 5. Other histologies than those described in the inclusion criteria 6. Current diagnosis of the following: follicular lymphoma Grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma ; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; CNS lymphoma , primary effusion DLBCL, and primary cutaneous DLBCL. 7. Prior treatment with cytotoxic drugs within 5 years of screening for any condition (e.g., cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody 8. Prior use of any monoclonal antibody within 3 months of the start of Cycle 1; any investigational therapy within 28 days prior to the start of Cycle 1; vaccination with live vaccines within 28 days prior the start of Cycle 1 9. Prior radiotherapy to the mediastinal/pericardial region 10. Prior therapy for DLBCL. Corticosteroids are addressed in the next point 11. Corticosteroid use more than 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control: -Patients receiving corticosteroid treatment with less than equal to 30 mg/day of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of Cycle 1. -Patients who require lymphoma symptom control during screening may receive steroids in the following manner: Up to 30 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of more than 30 to 100 mg/day of prednisone or equivalent. Prednisone more than 30 to 100 mg/day or equivalent may be given for a maximum of 7 days as a pre-phase treatment 12. History of other malignancy that could affect compliance with the protocol or interpretation of results 13. Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease 14. Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis 15. History or presence of an abnormal ECG that is clinically significant in the investigators opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction. 16. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1. 17. Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Incidence of any adverse events -Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to adverse events -Dose intensities of study drugs Timepoint: -Outcome will be assess at every patient visits Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, and study completion visit | — |
Secondary
| Measure | Time frame |
|---|---|
| -ORR at end of treatment by fluorodeoxyglucose positron emission tomography (FDG-PET) as determined by the investigator -CR rate at end of treatment by FDG-PET as determined by the investigatorTimepoint: Outcome will be assess at Screening & study completion visits | — |
Countries
India
Contacts
Public ContactSharad Junnare
Roche Products India Pvt. Ltd
Outcome results
None listed