RECRUITING

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

Official Title

A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia

Quick Facts

Study Start:2023-12-29
Study Completion:2027-06-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06137118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 16 years and older (Part A), 12 years and older (Parts B and C).
  2. * Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:
  3. 1. Bone marrow infiltration with \>/= 5% blasts
  4. 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
  5. 3. Philadelphia positive participants are allowed in Part A if intolerant or refractory to TKIs.
  6. * 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%.
  1. * Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).
  2. * Isolated extramedullary disease relapse.
  3. * Testicular leukemia
  4. * 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.
  5. * History of other malignancy (with certain exceptions).
  6. * Unresolved AEs \>/= Grade 2, from prior therapies
  7. * 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.
  8. * GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Duarte, California, 91010
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Palo Alto, California, 94304
United States
Research Site
Tampa, Florida, 33612
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
New York, New York, 10016
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Richmond, Virginia, 23298
United States
Research Site
Seattle, Washington, 98109
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-29
Study Completion Date2027-06-29

Study Record Updates

Study Start Date2023-12-29
Study Completion Date2027-06-29

Terms related to this study

Keywords Provided by Researchers

  • B-cell acute lymphoblastic leukemia
  • Leukemia
  • B-lymphocytes
  • AZD0486

Additional Relevant MeSH Terms

  • B-cell Acute Lymphoblastic Leukemia (B-ALL)