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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:
22.01.2021

Wirkstoff:
Blinatumomab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 14)

Research Site
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The study aims to evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for

treatment of Acute Lymphoblastic Leukemia (ALL) and to determine the maximum tolerated dose

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

Ein-/Ausschlusskriterien

Summary of eligibility criteria, additional details may apply

Inclusion Criteria:

- Aged 18 years or older.

- Participants with B-ALL with Relapsed or Refractory disease after at least 2 cycles of

chemotherapy.

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

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

- Greater than 5% blasts in the bone marrow.

- 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.

- Negative pregnancy test in women of childbearing potential.

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 or psychosis.

- 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.

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

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.

- 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.

Studien-Rationale

Primary outcome:

1. Number of participants who experience dose limiting toxicities (DLTs) (Time Frame - Up to 34 days)

2. Number of participants who experience one or more treatment-emergent adverse events (TEAEs) (Time Frame - Up to approximately 29 weeks)

3. Number of participants who experience one or more serious treatment-emergent adverse event (TEAEs) (Time Frame - Up to approximately 29 weeks)

4. Number of participants who experience one or more treatment-related treatment-emergent adverse events (TEAEs) (Time Frame - Up to approximately 29 weeks)

5. Number of participants who experience one or more adverse events (AEs) (Time Frame - Up to approximately 29 weeks)

Secondary outcome:

1. Minimum concentration over the dosing interval (Cmin) of blinatumomab (Time Frame - Up to 68 days)

2. Maximum concentration (Cmax) of blinatumomab (Time Frame - Up to 68 days)

3. Time to reach maximum concentration (Tmax) of blinatumomab (Time Frame - Up to 68 days)

4. Area under the concentration-time curve (AUC) of blinatumomab (Time Frame - Up to 68 days)

5. Number of participants with incidence of anti-blinatumomab antibodies (Time Frame - Up to 68 days)

6. Rate of complete remission (CR) including complete remission with partial hematological recovery (CRh) (Time Frame - Up to 68 days)

Studien-Arme

  • Experimental: Blinatumomab: Dose escalation
    Cohorts of at least 3 participants each 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: Blinatumomab: Dose expansion
    Participants will be administered the recommend phase 2 dose (RP2D) determined from dose escalation stage to further assess safety, pharmacokinetics (PK), pharmacodynamic (PD), and efficacy.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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