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RecruitingLast updated:15 August 2023

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).

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People18+

Phase

I

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Trial Identifiers

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Commercial 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

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

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

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

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