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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) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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•Philogen S.p.A.

View on ClinicalTrials.gov

Summary

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

Detailed Description

Phase I - Dose definition: A prospective, open-label, multi-center Phase I dose escalation study in which cohorts of 3-6 patients will receive escalating doses of L19-IL2 in combination with a fixed dose of Rituximab (375 mg/m2). Phase II - Activity Evaluation: Open-label, multi-center, prospective study during which 14 enrolled patients will receive a fixed dose of Rituximab (375 mg/m2) in combination with L19-IL2 at the RD defined during the Phase I part of the study. The study is designed to establish whether L19-IL2, administered in combination with Rituximab is well tolerated and can achieve objective responses and clinical benefit to patients with relapsed or refractory DLBCL.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed CD 20-positive DLBCL
•Patients must have experienced relapse after or not have achieved CR with standard R-CHOP-like treatment and must be ineligible for autologous stem cell transplantation or must have relapsed/progressed after autologous or allogeneic stem cell transplantation. In this last case, time lapse between autologous stem cell transplantation and beginning of L19-IL2 treatment must not be less than 4 weeks; in case of allogeneic stem cell transplantation, L19-IL2 treatment can start 4 weeks after removal of immunosuppressive drug(s).
•Presence of measurable lesions according to Revised response criteria for malignant lymphoma
•Males or females, age ≥ 18 years
•ECOG performance status ≤ 2
•Life expectancy of at least 12 weeks
•Absolute neutrophil count \> 1.5 x 109/L
•Hemoglobin \> 8.0 g/dL
•Platelets \> 50 x 109/L
•Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl)
+9 more criteria

Exclusion Criteria

•Evidence of central nervous system lymphoma
•Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis \& Ti) or any cancer curatively treated \< 5 years prior to study entry
•Hypersensitivity to Rituximab or to murine proteins, or to any of its excipients (Sodium citrate, Polysorbate 80, Sodium chloride, Sodium hydroxide, Hydrochloric acid)
•History of HIV infection or infectious hepatitis B or C
•Presence of active, severe infections (e.g., tuberculosis, sepsis and opportunistic infections or any infection requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infections should be excluded from the study.
•Active graft-versus-host disease in patients with a history of allogeneic stem cell transplantation
•History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
•Inadequately controlled cardiac arrhythmias including atrial fibrillation
•Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria)
•Uncontrolled hypertension
+10 more criteria

Locations (1)

Münster University Hospital

Münster, Germany

Key Dates

Start Date

July 31, 2013

Primary Completion Date

September 1, 2023

Completion Date

September 29, 2023

Last Updated

October 10, 2023

Enrollment

ACTUAL participants

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

L19-IL2 - Ph I

DRUG

L19-IL2 at RD - Ph II

DRUG

Rituximab

DRUG

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NCT06043011

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)+4 more

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ENROLLING_BY_INVITATIONPHASE1

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

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Relapsed/Refractory B-cell LymphomasDiffuse Large B-Cell Lymphoma (DLBCL)+10 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

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