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JOURNAL ONKOLOGIE – STUDIE

A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

Rekrutierend

NCT-Nummer:
NCT04521231

Studienbeginn:
Januar 2021

Letztes Update:
22.03.2024

Wirkstoff:
Blinatumomab

Indikation (Clinical Trials):
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphoid

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 41)

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
12200 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Jena
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Koeln
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Leipzig
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Universitatsklinikum Ulm
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
New York University Langone Health
10016 New York
United StatesRekrutierend» Google-Maps
University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Fred Hutchinson Cancer Center
98109-1023 Seattle
United StatesAbgeschlossen» Google-Maps
University of Washington
98109-1023 Seattle
United StatesRekrutierend» Google-Maps
Austin Health, Austin Hospital
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
Universitaetsklinikum Allgemeines Krankenhaus Wien
1090 Wien
AustriaAbgeschlossen» Google-Maps
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
V5Z 1M9 Vancouver
CanadaRekrutierend» Google-Maps
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
59000 Lille
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Nice
06202 Nice cedex 3
FranceRekrutierend» Google-Maps
Institut Universitaire du Cancer Toulouse Oncopole
31059 Toulouse cedex 9
FranceRekrutierend» Google-Maps
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
24127 Bergamo
ItalyRekrutierend» Google-Maps
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
40138 Bologna
ItalyRekrutierend» Google-Maps
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
25123 Brescia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Policlinico Umberto I
00161 Roma
ItalyRekrutierend» Google-Maps
Akita University Hospital
010-8543 Akita-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
Fukushima Medical University Hospital
960-1295 Fukushima-shi
JapanRekrutierend» Google-Maps
Yokohama City University Medical Center
232-0024 Yokohama-shi
JapanRekrutierend» Google-Maps
Erasmus Medisch Centrum
3015 CN Rotterdam
NetherlandsRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Bagcilar Medipol Mega Universite Hastanesi
34214 Istanbul
TurkeyRekrutierend» Google-Maps
Izmir Ekonomi Universitesi Medical Point Hastanesi
35575 Izmir
TurkeyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC)

blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum

tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab.

It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Aged 18 years or older.

- Participants with B-precursor ALL with any of the following:

- Either refractory to primary induction therapy or refractory to at least 1

salvage therapy OR

- In untreated first, second, third or greater relapse or refractory relapse

- First Relapse is defined as achievement of first Complete Remission (CR)

[CR1] during upfront therapy then relapse during or after continuation

therapy

- Primary Refractory disease is defined as the absence of CR after standard

induction therapy

- Refractory relapse is defined as lack of CR after salvage treatment

- Second relapse or later relapse is defined as relapse after achieving a

second CR (CR2) in first or later salvage

- Refractory to salvage is defined as no attainment of CR after salvage

- Relapsed or Refractory at any time after first salvage therapy.

- Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT).

- Greater than or equal to 5% blasts in the Bone Marrow (Exception: Isolated Non-central

nervous system (CNS) extramedullary disease [EMD]).

- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

- Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant

or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

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

Exclusion Criteria:

- Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood

cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present

and/or clinical signs of CNS leukemia.

- History or presence of clinically relevant CNS pathology such as epilepsy, childhood

or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia,

Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe

(≥ grade 3) CNS events including immune effector cell-associated neurotoxicity

syndrome (ICANS) from prior chimeric antigen receptor T-cell (CAR T) or other T cell

engager therapies.

- Isolated Extramedullary (EM) Disease

- Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any

other disease or condition that could be exacerbated by the treatment or would

complicate protocol compliance.

- Testicular leukemia

- History of malignancy (with certain exceptions) other than ALL within 3 years prior to

start of protocol-specified therapy.

- Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy.

- Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy

(with certain exceptions).

- Immunotherapy within 4 weeks before start of protocol-specified therapy. Prior failed

cluster of differentiation (CD19) directed therapy such as prior blinatumomab or CD19

CAR T cells will be allowed, if treatment ended more than 4 weeks prior to start of

protocol therapy therapy and no prior CNS complications.

- Currently receiving treatment in or less than 30 days since ending treatment on

another investigational study(ies).

- Abnormal screening laboratory parameters.

- Female participant: Expected to breastfeed during treatment and for 96 hours after the

last dose of treatment.

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

Studien-Rationale

Primary outcome:

1. Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs) (Time Frame - Up to 29 days)

2. Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs) (Time Frame - Up to approximately 28 weeks)

3. Dose Escalation Phase: Number of participants who experience one or more serious TEAEs (Time Frame - Up to approximately 28 weeks)

4. Dose Escalation Phase: Number of participants who experience one or more treatment-related treatment-emergent adverse events (Time Frame - Up to approximately 28 weeks)

5. Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) (Time Frame - Up to approximately 28 weeks)

6. Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission (CR) (Time Frame - Up to 68 days)

7. Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission with partial hematological recovery (CRh) (Time Frame - Up to 68 days)

8. Phase 2 Ph-IIC: Maximum concentration (Cmax) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)

9. Phase 2 Ph-IIC: Average concentration (Cavg) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)

10. Phase 2 Ph-IIC: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)

11. Phase 2 Ph-IIC: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)

Secondary outcome:

1. Dose Escalation Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab (Time Frame - Up to approximately 28 weeks)

2. Dose Escalation Phase: Cmax of blinatumomab (Time Frame - Up to approximately 28 weeks)

3. Dose Escalation Phase: Tmax of blinatumomab (Time Frame - Up to approximately 28 weeks)

4. Dose Escalation Phase: AUC of blinatumomab (Time Frame - Up to approximately 28 weeks)

5. Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh (Time Frame - Up to 68 days)

6. Dose Escalation, Dose Expansion, and Ph-IIC: Number of participants with incidence of anti-blinatumomab antibody formation (Time Frame - Up to approximately 28 weeks)

7. Dose Expansion Phase: Cmin of blinatumomab (Time Frame - Up to approximately 28 weeks)

8. Dose Expansion Phase: Cmax of blinatumomab (Time Frame - Up to approximately 28 weeks)

9. Dose Expansion Phase: Tmax of blinatumomab (Time Frame - Up to approximately 28 weeks)

10. Dose Expansion Phase: AUC of blinatumomab (Time Frame - Up to approximately 28 weeks)

11. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Relapse-Free Survival in participants who achieve CR/CRh within the first 2 cycles(R/R B-ALL) (Time Frame - Up to 68 days)

12. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Overall survival (OS) (Time Frame - Up to approximately 28 weeks)

13. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Duration of complete response (Time Frame - Up to approximately 28 weeks)

14. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more TEAEs (Time Frame - Up to approximately 28 weeks)

15. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more serious treatment-emergent adverse event (Time Frame - Up to approximately 28 weeks)

16. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more treatment-related treatment-emergent adverse events (Time Frame - Up to approximately 28 weeks)

17. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more AEs (Time Frame - Up to approximately 28 weeks)

18. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Summary scores of quality of life at each assessment as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) (Time Frame - Baseline (Day 1) up to approximately 28 weeks)

19. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Change from baseline of quality of life as assessed by the EORTC QLQ-C30 (Time Frame - Baseline (Day 1) up to approximately 28 weeks)

Studien-Arme

  • Experimental: Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)
    Cohorts of at least 3 participants each will be treated with escalating doses of bilinatumomab 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 participants with R/R B-ALL will be enrolled to the preliminary recommended phase 2 dose (RP2D) and schedule determined from dose escalation phase. 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 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 RP2D determined from the dose expansion phase, in participants with R/R B-ALL.

Geprüfte Regime

  • Blinatumomab (AMG 103 / Blincyto® / ):
    Blinatumomab will be administered as a subcutaneous (SC) injection.

Quelle: ClinicalTrials.gov


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