Study Complete
Sponsor ID
20140286

A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma

Sponsor ID
20140286
Clinicaltrials.gov ID
NCT02961881
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

Primary Objective:

• To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations

Secondary Objectives:

• To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations

• To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously

• To determine the incidence of anti-blinatumomab antibody formation following SC administration

• To evaluate efficacy response following treatment with SC blinatumomab administration

Exploratory Objective:

• To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration

• To evaluate efficacy response following treatment with SC blinatumomab

administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation

Additional Study Details

Phase
Phase 1
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
36
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject grade of dose limiting toxicities (DLTs)

Timeframe: 37 months

Incidence of dose limiting toxicities (DLTs)

Timeframe: 37 months

Severity of dose limiting toxicities (DLTs)

Timeframe: 37 months

Adverse Events

Timeframe: 37 months

Secondary Outcome Measures

Blinatumomab PK parameters (clearance of blinatumomab) under cIV

Timeframe: 37 months

Blinatumomab PK parameters (volume of distribution of blinatumomab) under cIV

Timeframe: 37 months

Blinatumomab PK parameters (clearance of blinatumomab) under SC administrations

Timeframe: 37 months

Blinatumomab PK parameters (volume of distribution of blinatumomab) under SC administrations

Timeframe: 37 months

Maximum Tolerated Dose

Timeframe: 37 months

Incidence of anti-blinatumomab antibodies

Timeframe: 37 months

Overall Response Rate (ORR)

Timeframe: 37 months

Complete Response (CR)

Timeframe: 37 months

Partial Response (PR) as determined by best overall response (ORR) using Cheson criteria

Timeframe: 37 months

Locations

Location
Status
Contact Us
Location
IRCCS Istituto Clinico Humanitas
Rozzano MI, Italy, 20089
Status
Terminated
Location
Hopital Henri Mondor
Créteil Cedex, France, 94010
Status
Recruiting
Location
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy, 25123
Status
Recruiting
Location
Hopital Saint Louis
Paris Cedex 10, France, 75475
Status
Recruiting
Location
Hackensack University Medical Center
Hackensack, NJ, United States, 07601
Status
Terminated
Location
Universitatsklinikum Ulm
Ulm, Germany, 89081
Status
Recruiting
Showing {first} - {last} of {total} Results