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New treatment option for B-cell Acute Lymphoblastic Leukemia (B-ALL)
Official title AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
ClinicalTrials.gov ID: NCT06137118
What this study is testing
What is AZD0486?
AZD0486 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
- 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.
- 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
- Age: 12 years and above (Parts A, B and C).
- 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.
You likely can't join if
- 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...
- History of other malignancy (with certain exceptions).
- Unresolved AEs \>/= Grade 2, from prior therapies
See the full eligibility 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:
- 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%. The above is a...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Melbourne, Australia
- Porto Alegre, Brazil
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Changsha, China
- Chengdu, China
- Guangzhou, China
+ 51 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 Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 65 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.