CTIS2023-505840-20-00
Active, not recruiting
Phase 1
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 - D7405C00001
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astrazeneca AB
- Enrollment
- 153
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 16\-80 years old (Part A), 12\-80 years old (Parts B and C)., Participants with CD19\+ B\-cell Acute Lymphoblastic Leukemia by local lab with Bone marrow infiltration with \>/\= 5% blasts, Participants with CD19\+ B\-cell Acute Lymphoblastic Leukemia by local lab with Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option., Participants with CD19\+ B\-cell Acute Lymphoblastic Leukemia by local lab with Philadelphia positive participants are allowed in Part A if intolerant or refractory to TKIs., Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 OR Lansky score more or equal to 50%.
Exclusion Criteria
- •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 psychosis; or prior Grade 4 neurotoxicity with CAR\-T or TCE therapy., 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.
Outcomes
Primary Outcomes
Not specified
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