AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Recruiting Phase 1 Phase 2 Interventional Study
B-cell Acute Lymphoblastic Leukemia (B-ALL)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
236 (estimated)
Sponsor
AstraZeneca · Industry
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About This Trial
This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the r…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age: 12 years and above (Parts A, B and C). * Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with: 1. Bone marrow infiltration with \>/= 5% blasts 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 pri…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT