Recruitment Complete
Sponsor ID
20180257

A Study of Subcutaneous Blinatumomab Administration in Participants with R/R and MRD+ B-ALL

Sponsor ID
20180257
Clinicaltrials.gov ID
NCT04521231
EUCTIS ID
N/A
EudraCT ID
2023-506136-32

Study Details

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab.

The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.

Additional Study Details

Phase
Phase 1/Phase 2
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
181
Additional Study Details

Protocol Summary

Primary Outcome Measures

Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)

Timeframe: Up to 29 days

Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

Timeframe: Up to approximately 28 weeks

Dose Escalation Phase: Number of participants who experience one or more serious TEAEs

Timeframe: Up to approximately 28 weeks

Dose Escalation Phase: Number of participants who experience one or more treatment-related TEAEs

Timeframe: Up to approximately 28 weeks

Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) of Interest (AEIs)

Timeframe: Up to approximately 28 weeks

Dose Expansion and Phase 2 Ph-IIR cohort: Number of participants who achieve complete remission (CR) / complete remission with partial hematological recovery (CRh)

Timeframe: Up to 10 weeks

Phase 2 Ph-IIC cohort: Maximum concentration (Cmax) of blinatumomab SC1 and SC2

Timeframe: Up to approximately 4 weeks

Phase 2 Ph-IIC cohort: Average concentration (Cavg) of blinatumomab SC1 and SC2

Timeframe: Up to approximately 4 weeks

Phase 2 Ph-IIC cohort: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2

Timeframe: Up to approximately 4 weeks

Phase 2 Ph-IIC cohort: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2

Timeframe: Up to approximately 4 weeks

Phase 2 Ph-IIM cohort: Number of participants who achieve CR with MRD-negative response

Timeframe: Up to 10 weeks

Secondary Outcome Measures

Dose Escalation and Dose Expansion Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab

Timeframe: Up to approximately 10 weeks

Dose Escalation and Dose Expansion Phase: Cmax of blinatumomab

Timeframe: Up to approximately 10 weeks

Dose Escalation and Dose Expansion Phase: Tmax of blinatumomab

Timeframe: Up to approximately 10 weeks

Dose Escalation and Dose Expansion Phase: AUC of blinatumomab

Timeframe: Up to approximately 10 weeks

Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh

Timeframe: Up to 10 weeks

Dose Escalation Phase, Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants with incidence of anti-blinatumomab antibody formation

Timeframe: Up to approximately 28 weeks

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Overall survival (OS)

Timeframe: Up to approximately 2 years

Dose Expansion Phase and Phase 2 (Ph-IIR cohort and Ph-IIC cohort): Duration of response

Timeframe: Up to approximately 2 years

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Relapse free survival

Timeframe: Up to approximately 2 years

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more TEAEs

Timeframe: Up to approximately 28 weeks

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more serious treatment-emergent adverse event

Timeframe: Up to approximately 2 years

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more treatment-related treatment-emergent adverse events

Timeframe: Up to approximately 28 weeks

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more AEIs

Timeframe: Up to approximately 28 weeks

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Summary scores of quality of life at each assessment as assessed by the EORTC QLQ-C30 for participants aged ≥ 17 years at the time of consent

Timeframe: Baseline (Day 1) up to approximately 28 weeks

Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Change from baseline of quality of life as assessed by the EORTC QLQ-C30 for participants aged ≥ 17 years at the time of consent

Timeframe: Baseline (Day 1) up to approximately 28 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Summary scores of quality of life at each assessment as assessed by PedsQL Generic Core Scale for participants aged 12 to < 17 years at time of consent

Timeframe: Baseline (Day 1) up to approximately 28 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Change from baseline of quality of life as assessed by PedsQL Generic Core Scale for participants aged 12 to < 17 years at time of consent

Timeframe: Baseline (Day 1) up to approximately 28 weeks

Phase 2 (Ph-IIR cohort): Number of participants who achieve CR

Timeframe: Up to 10 weeks

Phase 2 (Ph-IIR cohort): Number of participants who achieve CR, CRh, CRi (complete remission with incomplete hematological recovery) or blast free hypoplastic or aplastic bone marrow (BM)

Timeframe: Up to 10 weeks

Phase 2 (Ph-IIM cohort): Number of participants who achieve CR, CRh, CRi or blast free hypoplastic or aplastic BM with MRD-negative response

Timeframe: Up to 10 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Number of participants who achieve CR or CRh with MRD-negative response

Timeframe: Up to 10 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Duration of molecular response

Timeframe: Up to approximately 2 years

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Cmax of blinatumomab for participants participating in intense PK sampling assessment

Timeframe: Up to approximately 4 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Tmax of blinatumomab for participants participating in intense PK sampling assessment

Timeframe: Up to approximately 4 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): AUC of blinatumomab for participants participating in intense PK sampling assessment

Timeframe: Up to approximately 4 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Blinatumomab serum concentrations for participants not participating in intense PK sampling assessment

Timeframe: Up to approximately 4 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Proportion of time on treatment with high side effect bother from baseline to end of treatment as measured by Functional Assessment of Chronic Illness Therapy (FACIT) GP5 item for participants aged ≥ 17 years

Timeframe: Baseline (Day 1) up to approximately 28 weeks

Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Pain difference between pain score before and after injection as reported using the Numeric Rating Scale (NRS-11) for participants aged 12 to < 17 years at time of consent

Timeframe: Up to approximately 28 weeks

Locations

Location
Status
Contact Us
Location
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, Italy, 24127
Status
Recruiting
Location
Charite – Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting
Location
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Status
Recruiting
Location
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, France, 59000
Status
Recruiting
Location
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Status
Recruiting
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