A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Sponsor
Philogen S.p.A.
Study ID
NCT02957019
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Diffuse Large B-cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • L19-IL2 - Ph I — DRUG
    Patients will receive increasing doses of L19-IL2 (0.32, 0.43, 0.57 and 0.76 Mio IU/kg of IL-2 equivalents per administration) during Phase I study
  • L19-IL2 at RD - Ph II — DRUG
    Patients will receive L19-IL2 at the RD defined during the Phase I part of the study
  • Rituximab — DRUG
    Patients will receive a fixed dose of Rituximab (375 mg/m2) per administration during Phase I and Phase II of the study

Study Details

Phase I/II, open-label, multicenter, prospective study.

Key Dates

Start date
Jul 31, 2013
Status verified
Oct 2023
Primary completion
Sep 30, 2023
Completion
Sep 29, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: L19-IL2 + RTX
    Phase I (Dose definition): Cohorts of 3-6 patients will receive Rituximab on day 1 and 8 of the first 3-weeks cycle (C1D1 and C1D8, respectively) and on day 1 of the second 3-weeks cycle (C2D1). During two uninterrupted 3-weeks cycles, L19-IL2 will be administered on C1D1, C1D8, C1D15 and C2D1, C2D8, C2D15. Phase II (Activity Evaluation): During Phase II, 14 patients will receive Rituximab on C1D1 and C1D8 and on C2D1. Two uninterrupted 3-weeks cycles of L19-IL2 at the RD determined during Phase I will be administered on C1D1, C1D8 and C1D15 and C2D1, C2D8 and C2D15.

Primary Outcome Measure

Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage - phase I study [ Time Frame: Up to Day 21 of the Cycle 1 (cycle of 21 days) ]

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