Health Condition 1: null- Non Hodgkins Lymphoma
Conditions
Interventions
Intervention1: BVX 20: BVX 20
Intervention2: BVX20: Cohort 1 - 3 patients will be enrolled into 100 mg/dose - once weekly infusions for 4 weeks
Intervention3: BVX20: Cohot 2 to 5 - 10 patients will be
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: ? Patients with histologically confirmed relapsed/refractory mature B cell CD20+ lymphoma [either follicular lymphoma (FL), WHO grade I, II, IIIa or aggressive lymphoma (FL WHO grade IIIb, Bulky disease, or Diffuse Large B cell lymphoma (DLBCL))] ? Bi-dimensionally measurable disease documented at or within 28 days of enrolment, as defined by two or more clearly demarcated lesions on CT with largest diameter ≥1.5 cm OR a single lesion with largest diameter ≥2.0 cm. ? Must be willing to undergo upto 2 bone marrow aspirations during the trial ? Less than 5000 circulating lymphoid cells per μl on a WBC differential count Relapse/Refractory Patients - definition: - Patients should have progressed after completion of the previous NHL treatment which had induced CR, CRu or PR for at least 3 months (6 months for rituximab-based therapy), or be refractory to any NHL treatment for at least 6 months. Patients who have relapsed following anti-CD20 therapy must not have relapsed or progressed within 6 months of starting therapy or while receiving anti-CD20 therapy
Exclusion criteria
Exclusion criteria: ? Other types of CD20+ lymphoma, other than those mentioned in inclusion criteria ? Evidence of central nervous system involvement by lymphoma ? Previous radio-immunotherapy or stem cell transplantation ? Received mitomycin or nitrosureas within 6 weeks prior to enrolment ? Received anti-cancer therapy, glucocorticosteriods (10 mg/day) or radiation within 4 weeks prior to enrolment ? Received rituximab within 6 months before inclusion or has received more than 2 cycles of treatment with rituximab previously regardless of response ? Previous treatment with rituximab resulting in less than partial response or duration of response less than 6 months ? Documented intolerance or contraindication to glucocorticosteriod use ? HIV or Hepatitis B or C positivity ? More than 10 x 109/L circulating CD20+ lymphoma cells, platelets 75000/μL, neutrophils 1500 /μL, serum creatinine 1.5 times upper normal limit (unless normal creatinine clearance), total bilirubin 1.5 times upper normal limit (unless due to liver involvement of lymphoma), alanine amino transferase or alkaline phosphatase 2.5 times upper normal limit (unless due to liver involvement of lymphoma) ? WHO performance status 3 or 4 (Appendix 33.3) ? Clinical suspicion of active or latent tuberculosis infection or positive Mantoux test for tuberculosis (20 mm induration or ≤20 mm ulcerative or bullous lesion on 5 TU Mantoux test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of BVX20 monotherapy and identification of the MTD for BVX20Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of BVX20, Immunogenicity, Pharmacokinetics of BVX20Timepoint: 2 months, 6 months and 2 years | — |
Countries
India
Contacts
Public ContactMs Jayanti Panda
Biocon Research Limited
Outcome results
None listed