Last updated 23 days ago

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

142 patients around the world

Available in Spain, United States, Brazil

This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.

AstraZeneca

142Patients around the world

This study is for people with

Leukemia

Acute lymphoblastic leukemia

From 12 Years

All Gender

: Age: 12 years and above.
Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with.
Bone marrow infiltration with >= 5% blasts.
Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs.
For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
For Participants 16 years or younger, Lansky score more or equal to 50%.

: Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF.
Isolated extramedullary disease relapse.
Testicular leukemia.
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
Prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
History of other malignancy.
Unresolved AEs >= Grade 2, from prior therapies.
Prior therapy with TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.
GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.

StudySYRUS

SponsorAstraZeneca

Study typeInterventional

Conditions

Acute lymphoblastic leukemia

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06137118