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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)

NCT02957019 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-10-10

No results posted yet for this study

Summary

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

Conditions

  • Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

DRUG

L19-IL2 - Ph I

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

DRUG

L19-IL2 at RD - Ph II

Patients will receive L19-IL2 at the RD defined during the Phase I part of the study

DRUG

Rituximab

Patients will receive a fixed dose of Rituximab (375 mg/m2) per administration during Phase I and Phase II of the study

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2023-09-30
Completion
2023-09-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02957019 on ClinicalTrials.gov