A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
Condition(s) studied
Investigational drug(s) / intervention(s)
Blinatumomab: Blinatumomab will be administered as a subcutaneous (SC) injection.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs) — Up to 29 days
- Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs) — Up to approximately 28 weeks
- Dose Escalation Phase: Number of participants who experience one or more serious TEAEs — Up to approximately 28 weeks
- Dose Escalation Phase: Number of participants who experience one or more treatment-related TEAEs — Up to approximately 28 weeks
- Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) of Interest (AEIs) — 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) — Up to 10 weeks
- Phase 2 Ph-IIC cohort: Maximum concentration (Cmax) of blinatumomab SC1 and SC2 — Up to approximately 4 weeks
- Phase 2 Ph-IIC cohort: Average concentration (Cavg) of blinatumomab SC1 and SC2 — Up to approximately 4 weeks
- Phase 2 Ph-IIC cohort: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2 — Up to approximately 4 weeks
- Phase 2 Ph-IIC cohort: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2 — Up to approximately 4 weeks
- Phase 2 Ph-IIM cohort: Number of participants who achieve CR with MRD-negative response — Up to 10 weeks
Trial sites (109)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Francisco Fresno at Community Cancer Institute | Clovis | California | |
| City of Hope National Medical Center | Duarte | California | |
| University of Illinois Chicago | Chicago | Illinois | |
| Johns Hopkins University | Baltimore | Maryland | |
| C.S. Mott Children's Hospital - University of Michigan | Ann Arbor | Michigan | |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | |
| New York University Grossman School of Medicine and New York University Langone Hospitals | New York | New York | |
| Albert Einstein College of Medicine - Montefiore Medical Center | The Bronx | New York | |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | |
| St Jude Childrens Research Hospital | Memphis | Tennessee | |
| University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Fred Hutchinson Cancer Center | Seattle | Washington | |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | |
| Hospital Italiano de Buenos Aires | Ciudad Autonoma de Buenos Aires | Buenos Aires | |
| Sanatorio Allende | Córdoba | Córdoba Province | |
| Instituto Alexander Fleming | Buenos Aires | Argentina | |
| Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno | Ciudad Autonoma Buenos Aires | Argentina | |
| Sydney Childrens Hospital | Randwick | New South Wales | |
| Westmead Hospital | Westmead | New South Wales | |
| Queensland Childrens Hospital | South Brisbane | Queensland | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Monash Medical Centre | Clayton | Victoria | |
| Austin Health, Austin Hospital | Heidelberg | Victoria | |
| The Alfred Hospital | Melbourne | Victoria | |
| Perth Childrens Hospital | Nedlands | Western Australia | |
| Universitaetsklinikum Allgemeines Krankenhaus Wien | Vienna | Austria | |
| Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne | Yvoir | Belgium | |
| Hospital Sirio Libanes Brasilia | Brasília | Federal District | |
| Instituto Medicina Integral Imip | Recife | Pernambuco | |
| Hosp de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | |
| Fundacao Amaral Carvalho | Jaú | São Paulo | |
| Hosp Clin Fac Med Ribeirao Preto Usp | Ribeirão Preto | São Paulo | |
| Instituto Onco Ped Graac Unifesp | São Paulo | São Paulo | |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | |
| University of Alberta | Edmonton | Alberta | |
| Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre | Vancouver | British Columbia | |
| The Hospital for Sick Children | Toronto | Ontario | |
| Princess Margaret Cancer Centre | Toronto | Ontario | |
| Beijing Childrens Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Fujian Medical University Union Hospital | Fuzhou | Fujian |
+ 69 more sites — see the full list on the official registry below.
More Amgen trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04521231 on ClinicalTrials.gov ↗ ← All trials in Italy