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RecruitingLast updated: 2 February 2024

This study is evaluating how safe, tolerable and effective targeted therapy is for the treatment of Acute Lymphoblastic LeukaemiaA Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, 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 summary

Summary

This study has two parts. Eligible participants will be assigned to one of the two parts. In Part One (Dose Escalation), cohorts of participants will be treated with escalating doses of targeted therapy (blinatumomab) to determine the maximum tolerated dose. Blinatumomab will be administered as an injection (subcutaneous injection). In Part Two (Dose Expansion), four cohorts of participants with relapsed or refractory B-cell Acute Lymphoblastic Leukaemia will be enrolled to receive the preliminary recommended phase 2 dose that was determined in Part One (Dose Escalation).

Conditions

This trial is treating patients with B-precursor acute lymphoblastic leakaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, 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)

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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