From the Guidelines
Diagnostic findings in acute lymphocytic leukemia (ALL) include abnormal complete blood count results, bone marrow aspiration and biopsy revealing hypercellular marrow with >20% lymphoblasts, and flow cytometry identifying characteristic cell surface markers, as recommended by the most recent guidelines 1. The diagnosis of ALL generally requires demonstration of ≥20% bone marrow lymphoblasts upon hematopathology review of bone marrow aspirate and biopsy materials, which includes morphologic assessment, comprehensive flow cytometric and/or molecular characterization of the leukemic clone, and assessment of cytogenetic or molecular abnormalities 1. Some key diagnostic findings in ALL include:
- Abnormal complete blood count results showing anemia, thrombocytopenia, and either increased, normal, or decreased white blood cell counts with lymphoblasts present in peripheral blood
- Bone marrow aspiration and biopsy revealing hypercellular marrow with >20% lymphoblasts
- Flow cytometry identifying characteristic cell surface markers like CD19, CD20, CD10, and TdT
- Cytogenetic analysis showing chromosomal abnormalities such as t(9;22) Philadelphia chromosome or t(12;21)
- Lumbar puncture evaluating central nervous system involvement
- Additional tests including comprehensive metabolic panel, elevated LDH and uric acid levels, and coagulation studies that may reveal disseminated intravascular coagulation
- Immunophenotyping classifying ALL into B-cell (more common) or T-cell lineages, which guides treatment decisions
- Molecular studies detecting genetic mutations like BCR-ABL1, which significantly impact prognosis and treatment approach, as stated in the guidelines 1. These comprehensive diagnostic findings enable accurate classification, risk stratification, and appropriate treatment planning for ALL patients, with the most recent guidelines providing the best approach for diagnosis and treatment 1.
From the FDA Drug Label
INDICATIONS AND USAGE BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.
The diagnostic findings in acute lymphocytic leukemia (ALL) are not explicitly stated in the provided drug label. However, it mentions minimal residual disease (MRD) and CD19-positive B-cell precursor as relevant factors in the treatment of ALL.
- MRD is an important factor in the treatment of ALL, with an MRD level of greater than or equal to 0.1% being an indication for treatment with BLINCYTO.
- CD19-positive B-cell precursor is a specific type of ALL that is targeted by the drug BLINCYTO. 2
From the Research
Diagnostic Findings in Acute Lymphocytic Leukemia (ALL)
The diagnostic findings in acute lymphocytic leukemia (ALL) involve a multistep procedure that relies on the simultaneous application of multiple techniques, including:
- Cytomorphology
- Immunophenotype
- Cytogenetic assays 3 These techniques have important clinical implications for both diagnosis and predicting response to specific treatment regimens.
Prognostic Factors
Several prognostic factors have been identified in ALL, and a risk stratification at diagnosis and during follow-up is based on the characteristics of the leukemic cells 3.
Presentation of ALL
ALL can present in different ways, including:
- Malignant lymphoblasts invading the bone marrow and peripheral blood, which is the usual presentation 4
- Pancytopenia and a hypoplastic bone marrow, leading to an initial diagnosis of aplastic anemia 4 In some cases, patients may experience clinical improvement with normalization of the complete blood count within six months, or after initiating steroid therapy 4.
Diagnosis and Treatment
The diagnosis of ALL is typically established through bone marrow aspirate and bone marrow biopsy 4. Treatment of ALL usually involves standard chemotherapy, which can be successful in achieving complete remission 4.