A Phase I/II First in Human, Open Label, Multi-centre, Dose Escalation, Dose Finding, Safety and Tolerability Study of BVX20 administered intravenously in patients with Relapsed/Refractory CD20+ B cell Non Hodgkin?s Lymphoma - NI

Biocon Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•?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

•?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)

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