Actively Recruiting
Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
Led by AstraZeneca · Updated on 2026-05-11
83
Participants Needed
26
Research Sites
137 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
CONDITIONS
Official Title
Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older for Module 1 (18 years or older in the US) and 12 years or older for Module 2
- Known diagnosis of CD22-positive B-cell acute lymphoblastic leukemia based on WHO criteria
- Relapsed or refractory B-ALL (relapsed defined as bone marrow blasts > 5% or reappearance of blasts in peripheral blood)
- Module 1 includes Philadelphia chromosome-positive and negative B-ALL; Module 2 includes relapsed/refractory Philadelphia chromosome-negative B-ALL
- Performance status of ECOG 2 or less, Karnofsky Performance Status 50 or higher, or Lansky Performance Status 50 or higher
- Peripheral lymphoblast count less than 10,000/µL (cytoreduction allowed before treatment start)
- At least two prior therapies with relapse or refractoriness, or one prior therapy with relapse or refractoriness and no standard treatment options available
- For Philadelphia chromosome-positive B-ALL in Module 1, intolerance or contraindications to tyrosine kinase inhibitor therapy, or relapsed/refractory disease despite treatment with at least two prior TKIs or at least one third-generation TKI
- Prior donor lymphocyte infusion more than 4 weeks ago, prior cell therapy or autologous hematopoietic stem cell transplant more than 8 weeks ago, allogeneic hematopoietic stem cell transplant more than 12 weeks ago
You will not qualify if you...
- Burkitt lymphoma and leukemia
- Isolated extramedullary disease or active testicular or central nervous system involvement beyond CNS1
- Unresolved non-hematologic toxicities grade 2 or higher (except alopecia, stable grade 2 or less neuropathy, vitiligo, or endocrine disorders controlled with therapy)
- History of drug-induced non-infectious interstitial lung disease or pneumonitis requiring steroids or oxygen, or suspected cases not ruled out by imaging
- Recent therapies:
- Cytotoxic treatment within 14 days (except maintenance or cytoreduction for acute lymphoblastic leukemia)
- Biologic immuno-oncology treatments within 28 days or five half-lives (whichever is shorter)
- Non-central nervous system radiation within 2 weeks and CNS radiation within 4 weeks
- Medications that prolong QTc or are associated with Torsades de Pointes within five half-lives
- Strong CYP3A4 inhibitors within 14 days or five half-lives (whichever is longer)
- Investigational agents or study interventions within 30 days or five half-lives prior to first dose of AZD4512 unless specified washout periods for B-ALL treatments are met
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Research Site
Duarte, California, United States, 91010
Actively Recruiting
2
Research Site
Jacksonville, Florida, United States, 32224
Withdrawn
3
Research Site
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Research Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Research Site
Franklin, Tennessee, United States, 37067
Actively Recruiting
6
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
7
Research Site
Melbourne, Australia, 3000
Actively Recruiting
8
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Not Yet Recruiting
9
Research Site
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
10
Research Site
Guangzhou, China, 510515
Not Yet Recruiting
11
Research Site
Tianjin, China, 301600
Not Yet Recruiting
12
Research Site
Bunkyō City, Japan, 113-8677
Actively Recruiting
13
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
14
Research Site
Seoul, South Korea, 03080
Actively Recruiting
15
Research Site
Seoul, South Korea, 06351
Actively Recruiting
16
Research Site
Seoul, South Korea, 06591
Actively Recruiting
17
Research Site
Seoul, South Korea, 3722
Actively Recruiting
18
Research Site
Badalona(Barcelona), Spain, 08916
Not Yet Recruiting
19
Research Site
Barcelona, Spain, 08035
Actively Recruiting
20
Research Site
Salamanca, Spain, 37007
Actively Recruiting
21
Research Site
Santander, Spain, 39008
Actively Recruiting
22
Research Site
Valencia, Spain, 46026
Withdrawn
23
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
24
Research Site
Taipei, Taiwan, 106
Actively Recruiting
25
Research Site
Bloomsbury, United Kingdom, W1T 7HA
Actively Recruiting
26
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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