Phase
Condition
Leukemia
Lymphoproliferative Disorders
Lymphocytic Leukemia, Acute
Treatment
WU-CART-007
Clinical Study ID
Ages > 1 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World HealthOrganization (WHO) classification, and either relapse/refractory or MRD positive,defined as:
Relapsed or Refractory Cohort: disease defined by bone marrow with ≥5%lymphoblasts by morphologic assessment or flow cytometry or evidence ofextramedullary disease (EMD).
Minimal Residual Disease (MRD) Cohort: evidence of MRD, defined as < 5% blastsin bone marrow but ≥ 0.01% blasts determined by central laboratory flowcytometry assay
Adequate Organ Function
Age: Lower age limit of ≥ 1 year.
Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/60 andabove at Screening (Adults age > 16) or Lansky Performance Status 60 and above (pediatrics/ adolescents age ≤16).
Exclusion
Key Exclusion Criteria:
Treatment with any prior anti-CD7 therapy.
Patients with decompensated hemolytic anemia.
Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemicimmunosuppression (e.g. steroids). Grade 1 GvHD not requiring immunosuppression orGrade 2 skin GvHD if treated with topical therapy only are acceptable.
Study Design
Study Description
Connect with a study center
Peter Mac Callum Cancer Institute
Melbourne, Victoria 3000
AustraliaSite Not Available
Royal Children's Melbourne
Melbourne, Victoria 3000
AustraliaSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Children's Hospital Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
Moffit Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Washington University Saint Louis
Saint Louis, Missouri 63108
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19390
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
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