A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL

Who is this study for? Adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia
What treatments are being studied? Blinatumomab
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Ph-IIC, Dose Escalation and Dose Expansion: Aged 18 years or older (or same or greater than legal age within the country if it is older than 18 years).

• Ph-IIRa and Ph-IIMa: Aged ≥ 17 years at time of informed consent.

• Ph-IIRb and Ph-IIMb: Age ≥ 12 years and \< 17 years at time of informed consent.

• Ph-IIR, Ph-IIC, Dose escalation, Dose Expansion: Participants with R/R B-precursor ALL.

• Relapsed or Refractory B-precursor ALL at any time after first salvage therapy.

• Relapsed B-precursor ALL at any time after allogenic hematopoietic stem cell transplant (HSCT).

• Ph-IIR, Ph-IIC, Dose escalation, Dose expansion: Greater than or equal to 5% blasts in the Bone Marrow per local assessment.

• Ph-IIM: B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and \< 5% per local assessment.

• Ph-IIM: Availability of an appropriate archival BM specimen from initial or relapse diagnosis and the screening BM sample.

• Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

• Participants aged 16 to \< 18 years old: Karnofsky Performance Score ≥ 50%.

• Participants aged \< 16 years old: Lansky Performance Score ≥ 50%.

• Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

• Ph-IIM: BM function as follows:

‣ Absolute Neutrophil Count (ANC) ≥ 500/μL

⁃ Platelet count ≥ 50 000/μL (transfusion permitted)

⁃ Hemoglobin level ≥ 9 g/dL (transfusion permitted)

∙ The above is a summary, other inclusion criteria details may apply.

Locations
United States
California
City of Hope National Medical Center
RECRUITING
Duarte
New York
New York University Grossman School of Medicine and New York University Langone Hospitals
RECRUITING
New York
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Fred Hutchinson Cancer Center
COMPLETED
Seattle
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Monash Medical Centre
RECRUITING
Clayton
Austin Health, Austin Hospital
RECRUITING
Heidelberg
The Alfred Hospital
RECRUITING
Melbourne
Westmead Hospital
RECRUITING
Westmead
Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
COMPLETED
Vienna
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
Princess Margaret Cancer Centre
RECRUITING
Toronto
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
RECRUITING
Vancouver
France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
RECRUITING
Lille
Centre Hospitalier Universitaire de Nice - Hopital l Archet
RECRUITING
Nice
Hopital Saint Antoine
RECRUITING
Paris
Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
Toulouse
Germany
Universitaetsklinikum Augsburg
RECRUITING
Augsburg
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
RECRUITING
Berlin
Universitaetsklinikum Koeln
RECRUITING
Cologne
Universitaetsklinikum Jena
RECRUITING
Jena
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Universitaetsklinikum Tuebingen
COMPLETED
Tübingen
Universitatsklinikum Ulm
RECRUITING
Ulm
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
RECRUITING
Bergamo
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
RECRUITING
Brescia
IRCCS Ospedale San Raffaele
COMPLETED
Milan
Azienda Ospedaliera Policlinico Umberto I
RECRUITING
Roma
Japan
Akita University Hospital
RECRUITING
Akita
Fukushima Medical University Hospital
RECRUITING
Fukushima
National Cancer Center Hospital East
RECRUITING
Kashiwa-shi
Yokohama City University Medical Center
RECRUITING
Yokohama
Netherlands
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen del Rocio
COMPLETED
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Turkey
Bagcilar Medipol Mega Universite Hastanesi
RECRUITING
Istanbul
Izmir Ekonomi Universitesi Medical Point Hastanesi
RECRUITING
Izmir
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2021-01-04
Estimated Completion Date: 2029-05-25
Participants
Target number of participants: 281
Treatments
Experimental: Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)
Cohorts of at least 3 adult participants with R/R B-ALL will be treated with escalating doses of blinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.
Experimental: Dose Expansion Phase: Blinatumomab SC1
Up to 4 cohorts of adult participants with R/R B-ALL will be enrolled at different dose levels to support identification of the RP2D. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.
Experimental: Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations
1 cohort of adult participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the preliminary RP2D determined from the dose expansion phase, in participants with R/R B-ALL.
Experimental: Ph-IIR: Efficacy of SC Blinatumomab in Participants with R/R B-ALL
The efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with R/R B-ALL.
Experimental: Ph-IIM: Efficacy of SC Blinatumomab in Participants with MRD+ B-ALL
The efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with MRD+ B-ALL.
Sponsors
Leads: Amgen
Collaborators: BeiGene

This content was sourced from clinicaltrials.gov

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