Health Condition 1: C833- Diffuse large B-cell lymphoma Health Condition 2: C829- Follicular lymphoma, unspecified
Conditions
Interventions
Intervention1: Lutetium-177 Radiolabeled Rituximab (177Lu-Rituximab): Day 1: Cold rituximab 250mg/m2 to saturate non specific receptors (This is essential to increase the binding of Lutetium177 Rituxi
Sponsors
ACTREC Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with DLBCL Primary Mediastinal B cell Lymphoma PMBCL Follicular Lymphoma FL and Transformed FL with any one of the following criteria will be eligible to participate in the study - Primary refractory showing Stable disease or Progression after 4 cycles of first line chemo immunotherapy or relapsing within 3 months of completion of treatment -Refractory to second line or subsequent line of chemo immunotherapy showing Stable disease or Progression after 2 or more cycles of second line or subsequent line of chemotherapy -Relapse after Autologous bone marrow transplant Relapse Progression or Stable disease will be documented on FDG PET CT as per internationally accepted criteria and guidelines 2.Patients showing less than 25 percent marrow involvement by tumor cells on bone marrow biopsy 3.Age greater than or equal to 18 years 4.ECOG performance status less than or equal to 2 5.Normal haematological function Hb greater than 8 g per dl Platelet count greater than 75000 per cubic mm Absolute neutrophil count greater than 1000 per cubic mm Use of growth factors or transfusions to meet these requirements are permitted 6.Adequate renal function Calculated creatinine clearance greater than 30 ml per minute 7.Adequate liver function Total bilirubin less than 1.5 times institutional upper limit of normal AST SGOT or ALT SGPT less than or equal to 2.5 times institutional upper limit of normal 8.Serum albumin greater than 30 g per L or 3 g per dL 9.Patients who are not eligible for have no access to or are deemed unsuitable for standard of care therapies including CAR T cell therapy bispecific antibody therapy or salvage chemotherapy followed by autologous stem cell transplantation
Exclusion criteria
Exclusion criteria: 1.Past history of second malignancy 2.Participants who are receiving any other investigational agents. 3.Patients who have received any cancer directed therapy within 3 weeks of screening for this study. 4.Prior radiopharmaceutical therapy 5.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 6.Uncontrolled intercurrent illness including or psychiatric illness or social situations that would limit compliance with study requirements. 7.Pregnant women and breastfeeding women. Breast feeding women may be eligible if they agree to stop breast feeding completely for 1 year. 8.Patient s refusal to give informed consent and participate in the study. 9.Clinically significant or uncontrolled cardiac disease such as congestive heart failure requiring treatment (New York Heart Association more than Class 2, uncontrolled hypertension, clinically significant arrhythmia. 10. Acute coronary syndrome or acute myocardial infarction less than equal to 6 months prior to administration of study intervention. 11. Active HIV or HBV infections 12. Non-study-related minor surgical procedure less than equal to 5 days, or major surgical procedure less than equal to 21 days, prior to the administration of study intervention; in all cases, the participant must be sufficiently recovered and stable before treatment administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the objective response rate following Lu177-Rituximab in relapsed/ refractory DLBCL & Follicular Lymphoma Patients.Timepoint: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the 1 year PFS following Lu177-Rituximab therapy in relapsed/ refractory DLBCL & Follicular Lymphoma Patients. 2.To evaluate safety profile of Lu177 Rituximab therapy in relapsed/ refractory DLBCL & Follicular Lymphoma Patients in terms of incidence of more than equal to grade 3 toxicity Timepoint: 36 months | — |
Countries
India
Contacts
Public ContactDr Sachin Punatar
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre
Outcome results
None listed