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AZD0486 for Acute Lymphoblastic Leukemia (SYRUS Trial)

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%

Must not have

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

Unresolved adverse events >/= Grade 2, from prior therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

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.

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).

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious brain-related health issues like severe epilepsy, stroke, or dementia.

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I have no ongoing major side effects from previous treatments.

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My leukemia has spread to my brain or spinal cord.

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My cancer has returned outside the bone marrow.

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I have leukemia that has spread to my testicles.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Frequency of DLTs

Parts A & B: Safety Evaluation of AZD0486

Parts B & C: Overall Response Rate (ORR)

Secondary study objectives

Part A: Objective Response Rate (ORR)

Part C: Safety Evaluation of AZD0486

Parts A, B & C: PK Characterization of AZD0486

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 be evaluated prior declared safe-doses and schedules in order to determine the recommended phase 2 dose (RP2D). Participants, aged 12-80 years, will receive AZD0486 IV infusions and will be 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 / 7Eligibility criteria met