Clinical Trials /

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

NCT04521231

Description:

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.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients
  • Official Title: A Phase 1b Open-label Study to Investigate the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

Clinical Trial IDs

  • ORG STUDY ID: 20180257
  • SECONDARY ID: 2019-004780-52
  • NCT ID: NCT04521231

Conditions

  • B Cell Precursor Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
BlinatumomabAMG 103, Blincyto®Blinatumomab: Dose escalation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Blinatumomab: Dose escalationExperimentalCohorts 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.
  • Blinatumomab
Blinatumomab: Dose expansionExperimentalParticipants will be administered the recommend phase 2 dose (RP2D) determined from dose escalation stage to further assess safety, pharmacokinetics (PK), pharmacodynamic (PD), and efficacy.
  • Blinatumomab

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants who experience dose limiting toxicities (DLTs)
Time Frame:Up to 34 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Minimum concentration over the dosing interval (Cmin) of blinatumomab
Time Frame:Up to 68 days
Safety Issue:
Description:
Measure:Maximum concentration (Cmax) of blinatumomab
Time Frame:Up to 68 days
Safety Issue:
Description:
Measure:Time to reach maximum concentration (Tmax) of blinatumomab
Time Frame:Up to 68 days
Safety Issue:
Description:
Measure:Area under the concentration-time curve (AUC) of blinatumomab
Time Frame:Up to 68 days
Safety Issue:
Description:
Measure:Number of participants with incidence of anti-blinatumomab antibodies
Time Frame:Up to 68 days
Safety Issue:
Description:
Measure:Rate of complete remission (CR) including complete remission with partial hematological recovery (CRh)
Time Frame:Up to 68 days
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Amgen

Trial Keywords

  • R/R B-ALL
  • Blincyto®
  • AMG 103
  • Blinatumomab
  • Acute lymphoblastic leukemia (ALL)

Last Updated

August 18, 2020