NCT04524455 : A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

OnePhase One

18-99Age 18-99

Blood<br/>CancersCancer LocationBlood
Cancers

Treatment | Blood / Myeloma / LymphomaAcute Lymphoblastic Leukaemia

Trial Overview Read MoreRead more

This phase I trial is trying to understand how safe, tolerable and effective a combination of targeted therapies (blinatumomab and AMG 404) is in people with Acute Lymphoblastic Leukaemia (ALL).
 

This trial is treating patients with Acute Lymphoblastic Leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

Commercial Sponsor

AMGEN

Summary

This is a single group assignment trial seeking to evaluate blinatumomab in combination with AMG 404 in adults with acute lymphoblastic leukaemia (ALL), and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab. All participants in this trial will receive blinatumomab (via cIV) and AMG 404 (administered as an intravenous infusion. Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment as needed.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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