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New treatment option for B-cell Acute Lymphoblastic Leukemia (B-ALL)
Official title Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07109219
What this study is testing
What is AZD4512 monotherapy?
AZD4512 monotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia (b-all).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 1\. Age:
- 16 years old in Module 1 (US only: ≥18year)
- 12 years old in Module 2 2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).
- Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB)
- Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
You likely can't join if
- Burkitt lymphoma and leukemia
- Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement
- Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
- History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot...
- Prior/concomitant therapy
- Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)
See the full eligibility criteria
- 1\. Age:
- 16 years old in Module 1 (US only: ≥18year)
- 12 years old in Module 2 2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).
- Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB)
- Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
- Backfill of Module 1 and Module 2 (DO): R/R Ph(-) B-ALL 3\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50) 4\. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified...
- Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI 6\. Prior DLI \>4 weeks, prior cell...
- Burkitt lymphoma and leukemia
- Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement
- Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
- History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Prior/concomitant therapy
- Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)
- Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)
- Non-CNS radiation within 2 weeks \& CNS radiation within 4 weeks
- Medications known to prolong QTc and/or associated with Torsades de Pointes within 5 half-lives
- Strong inhibitors of CYP 3A4 within 14 days or 5 half-lives (whichever is longer)
- Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer. If the investigational product is an agent to treat B-ALL and meets the modality...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Franklin, Tennessee, United States
- Houston, Texas, United States
- Melbourne, Australia
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Guangzhou, China
- Tianjin, China
- Bunkyō City, Japan
- Chūōku, Japan
- Seoul, South Korea
- Badalona(Barcelona), Spain
- Barcelona, Spain
- Salamanca, Spain
- Santander, Spain
- Valencia, Spain
- Taichung, Taiwan
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States; Franklin, Tennessee, United States; Houston, Texas, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.