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AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
NCT06137118 · AstraZeneca
In plain English
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Official title
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia
About this study
This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.
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 prior line of therapy if no SOC available option.
3. 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%.
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria:
* Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).
* 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; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
* History of other malignancy (with certain exceptions).
* 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.
The above is a summary, other exclusion criteria details may apply.
Study design
Enrollment target: 236 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2023-12-29
Estimated completion: 2027-06-29
Last updated: 2026-05-27
Interventions
Drug: AZD0486
Primary outcomes
- • Part A: Frequency of DLTs (Up to 28 days)
- • Parts A & B: Safety Evaluation of AZD0486 (From signing of informed consent through data cutoff, up to 42 months)
- • Parts B & C: Rate of CR within 3 cycles (Up to three cycles of 28 days each)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (80)
Research SiteWithdrawn
Birmingham, Alabama, United States
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Duarte, California, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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New York, New York, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Melbourne, Australia
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Porto Alegre, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Changsha, China
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Chengdu, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Nanjing, China
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Nanjing, China
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Suzhou, China
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Tianjin, China
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Zhengzhou, China
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Caen, France
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Marseille, France
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Nantes, France
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Paris, France
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Pierre-Bénite, France
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Toulouse, France
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Cologne, Germany
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Düsseldorf, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Halle, Germany
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Hamburg, Germany
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Kiel, Germany
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München, Germany
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Münster, Germany
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Würzburg, Germany
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Bergamo, Italy
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Bologna, Italy
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Monza, Italy
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Naples, Italy
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Roma, Italy
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Bunkyō City, Japan
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Chiba, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Kashiwa, Japan
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Kyoto, Japan
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Okayama, Japan
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Osaka, Japan
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Sapporo, Japan
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Toyohashi, Japan
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Yamagata, Japan
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Salamanca, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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London, United Kingdom
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Manchester, United Kingdom
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Surrey, United Kingdom