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AZD0486 for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with CD19+ B-cell Acute Lymphoblastic Leukemia by local lab with bone marrow infiltration with >/= 5% blasts

Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 OR Lansky score more or equal to 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial will evaluate safety, tolerability, & efficacy of AZD0486 monotherapy in R/R B ALL patients who have had ≥ 2 prior therapies. 3 parts: dose escalation, dose optimisation & dose expansion at the RP2D.

Who is the study for?

This trial is for people aged 16+ (Part A) or 12+ (Parts B and C) with a type of blood cancer called CD19+ B-cell Acute Lymphoblastic Leukemia. They must have had at least two prior treatments, or one if no other options exist. Participants should be relatively active and not have severe brain conditions, unresolved serious side effects from past treatments, recent cell therapies or transplants, or active cancer in the brain.Check my eligibility

What is being tested?

The study tests AZD0486 as a single treatment for relapsed/refractory B-cell Acute Lymphoblastic Leukemia. It has three parts: dose escalation to find safe levels (Part A), dose optimization to refine the amount given (Part B), and expansion at the recommended phase 2 dose to see how well it works on more patients (Part C).See study design

What are the potential side effects?

Possible side effects are not detailed here but may include typical reactions related to immune system activation such as fever, fatigue, infusion-related reactions; organ inflammation; blood disorders; increased risk of infections; and neurological issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My leukemia involves more than 5% of bone marrow cells.

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I can do most activities or my child is mostly active and playful.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Frequency of DLTs

Parts A, B, C: Safety Evaluation of AZD0486

Parts B & C: Overall Response Rate (ORR)

Secondary outcome measures

Part A: Objective Response Rate (ORR)

Parts A, B & C: PK Characterization of AZD0486

Parts A, B, & C: PK characterization of AZD0486

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part C: Dose ExpansionExperimental Treatment1 Intervention

Part C will consist of 1 cohort of participants aged 12-80 years, treated with the optimal dose selected in Part B and receive IV AZD0486 monotherapy.

Group II: Part B: Dose OptimizationExperimental Treatment1 Intervention

Up to 2 cohorts will evaluated prior declared safe-doses and schedules in order to determine the recommended phase 2 dose (RP2D). Participants will receive AZD0486 IV infusions and randomized in a 1:1 ratio.

Group III: Part A: AZD0486 Dose EscalationExperimental Treatment1 Intervention

Ascending dose level cohorts of AZD0486 in B-ALL participants aged 16-80 years.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,555 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations have been selected to administer this trial?

"Presently, the trial is available at 26 sites spread across America. Such locations include Los Angeles, Tampa and Houston. When considering enrollment in this clinical study, it can beneficial to select a location closest you to minimize travel costs."

Answered by AI

What purpose does this research endeavor aim to accomplish?

"The primary objective of this 28-day clinical trial is to evaluate the safety of AZD0486. Secondary goals center around Duration of Response (DoR), Complete Remission Rate (CR) at any point during the study, and Event-Free Survival (EFS)."

Answered by AI

Are there enrollment opportunities in this clinical trial currently?

"The trial is not recruiting any more patients, as reported on clinicaltrials.gov. Initially posted in December 26th 2023 and last edited November 13th of the same year; this study has concluded recruitment but there are still 1 540 other medical trials that actively accept candidates."

Answered by AI

Does this clinical research offer enrollment to individuals over 45 years of age?

"This precise clinical trial stipulates that participants must be aged between 12 and 80 years. Among the other trials, there are 485 for those younger than 18 and 1,220 for those over 65."

Answered by AI

Who meets the eligibility criteria for participation in this medical experiment?

"The requirements to be accepted into this medical trial are an age of 12-80 and acute lymphoblastic leukemia. Approximately 120 participants will be involved in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

2023. "AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06137118.

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