Review the discovery findings

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Acute Lymphoblastic Leukemia United States All RUN-B09E17F3
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9 key insights from the discovery phase

Each card is one slot the research owes, filled from its stage document. Ready cards carry forward as written unless you change them; a card marked Needs review says why.

01

Epidemiology

Acute lymphocytic leukemia in the United States has SEER estimates of 6,250 new cases and 1,600 deaths in 2026, with 5-year relative survival of 73.2% for 2016–2022. The disease is most frequently diagnosed among people aged less than 20 years, with peak incidence between 2 and 5 years of age.

Approved by you Clinical Landscape
Approved by you | 8 sources |includes web evidence
6,250
New US cases per year
1,600
Deaths per year
1.9 per 100,000
Incidence rate
0.4 per 100,000
Mortality rate
126,118
US prevalence
73.2%
5-year survival
What this means

Claims-based ALL cohorts in the United States should expect concentration in pediatric, adolescent, and young adult populations. Survival and prevalence figures indicate a substantial population living with treated disease and potential longitudinal therapy exposure.

Sources
CDC / NCHS Orphanet / Orphadata NCI SEER National Cancer Institute (NCI)
02

Patient Population & Segmentation

The supplied materials support segmentation of ALL cohorts by age group, lineage subtype, Philadelphia chromosome status, relapse/remission state, and response/risk category. B-cell ALL and T-cell ALL are explicitly identified immunophenotypic subtypes, and Philadelphia chromosome-positive ALL is treated as a distinct therapeutic subgroup.

Clinical Landscape
Ready | 6 sources |includes web evidence
What this means

Lineage subtype, Philadelphia chromosome status, age group, and relapse/remission status are directly relevant cohort-defining forks for claims analyses. The supplied evidence does not provide operational MRD or performance-status segmentation criteria.

Worth checking: Check whether the cited B-ALL and T-ALL percentage shares are representative beyond the referenced study population.

Sources
National Cancer Institute (NCI) WHO Orphanet / Orphadata ASH / Blood (American Society of Hematology)
SegmentApproximate shareDefining feature
Children, adolescents, and young adultsNot quantifiedMost frequently diagnosed among people aged <20
B-cell acute lymphoblastic leukemia (B-ALL)79.3%CD19, CD22, cytoplasmic CD79a markers
T-cell acute lymphoblastic leukemia (T-ALL)20.7%Cytoplasmic CD3 and CD5 markers
Philadelphia chromosome-positive ALLNot providedImatinib incorporated into therapy
Philadelphia chromosome-like ALLNot providedPrecursor B-cell ALL chromosomal alteration subtype
Relapsed/refractory ALLNot providedGreater treatment resistance and higher risk
CR2 and greater remission statesNot providedSecond or greater remission referenced
03

Disease Definition & Taxonomy

ALL is defined as a group of rare Non-Hodgkin lymphoma characterized by malignant proliferation of lymphoid cells blocked at an early stage of differentiation. The disease primarily affects bone marrow and peripheral blood but can infiltrate any organ or tissue.

Clinical Landscape
Ready | 7 sources |includes web evidence
What this means

Disease taxonomy for claims-based analyses should preserve lineage subtype and Philadelphia chromosome status because these influence treatment selection. The supplied materials do not provide formal WHO/ICC diagnostic thresholds or comprehensive molecular classification schemas.

Worth checking: Confirm whether early T-cell precursor ALL wording reflects a direct source quotation or summary-level characterization.

Sources
Orphanet / Orphadata National Cancer Institute (NCI) WHO NCI SEER
ClassificationCategoryNote
Acute lymphoblastic leukemiaRare Non-Hodgkin lymphomaMalignant proliferation of lymphoid cells
Disease involvementBone marrow and peripheral bloodCan infiltrate any organ or tissue
B-cell ALLImmunophenotypic lineage subtypeCD19, CD22, cytoplasmic CD79a markers
T-cell ALLImmunophenotypic lineage subtypeCytoplasmic CD3 and CD5 markers
Philadelphia chromosome-positive ALLMolecular/cytogenetic subtypeImatinib incorporated into treatment
Philadelphia chromosome-like ALLPrecursor B-cell ALL subtypeChromosomal alteration subtype
Early T-cell precursor ALLRecognized subtypeReferenced in supplied summary text
04

Diagnostic Foundation

The supplied materials describe diagnosis around clinical presentation, marrow and blood involvement, immunophenotypic lineage assignment, and cytogenetic or molecular subtype evaluation including Philadelphia chromosome status.

Clinical Landscape
Ready | 4 sources |includes web evidence
  1. Assess presenting symptoms
  2. Evaluate marrow and blood involvement
  3. Assess extranodal tissue infiltration
  4. Perform immunophenotyping
  5. Identify B-cell lineage markers
  6. Identify T-cell lineage markers
  7. Evaluate cytogenetic or molecular subtype
  8. Determine Philadelphia chromosome status
What this means

Claims-based diagnostic identification can leverage lineage markers, disease site involvement, and Philadelphia chromosome-associated treatment patterns. The supplied evidence does not define formal blast thresholds, CNS workup standards, or MRD criteria.

Worth checking: Specific diagnostic assay methods and thresholds were not supplied and may require expert supplementation.

Sources
Orphanet / Orphadata National Cancer Institute (NCI) ASH / Blood (American Society of Hematology) Open Web (Supplementary)
05

Natural History & Disease Journey

The supplied materials describe ALL progression from presentation and diagnosis through subtype classification, treatment stratification, remission states, and relapsed or refractory disease.

Clinical Landscape
Ready | 6 sources |includes web evidence
  1. Present with systemic symptoms
  2. Diagnose marrow or blood disease
  3. Classify lineage subtype
  4. Assess Philadelphia chromosome status
  5. Select risk-adapted therapy
  6. Achieve remission state
  7. Monitor for relapse
  8. Treat relapsed or refractory disease
What this means

Disease course and line-of-therapy analyses should account for remission transitions and relapsed or refractory states, especially across lineage and Philadelphia chromosome-defined subgroups. Age setting differences between pediatric and adult care may also affect treatment sequencing.

Worth checking: The supplied materials reference CR2 and greater remission states without operational timing definitions.

Sources
Orphanet / Orphadata National Cancer Institute (NCI) NCI SEER PubMed
06

Treatment Landscape

The supplied documents do not provide a comprehensive list of United States first-line treatment regimens for acute lymphoblastic leukemia across induction, consolidation, maintenance, and MRD-positive settings stratified by guideline preference categories. The documents do identify some guideline or cooperative-group treatment approaches and disease subsets. An ASCO Educational Book review states that “Contemporary COG HR ALL treatment regimens were developed from the BFM-76 regimen, with subse

Approved by you Treatment Evidence
Approved by you | 9 sources |includes web evidence

Was flagged: No source returned usable evidence. Add what you know, or tell Celestra where to look. Settled by your decision.

Sources
FDA ESMO FDA Drug Labeling (openFDA) National Cancer Institute (NCI)
AgentClass or MOAStatus: approved / compendia-supported / off-labelApproved lineBiomarker restrictionApproval datePrimary code
FDA grants accelerated approval to ponatinib with chemotherapy for ... Chemotherapy consisted of 3 cycles of induction with vincristine and dexamethasone, 6 cycles of consolidation alternating between methotrexate and cytarabine, and 11 cycles of maintenance with vincristine and prednisone. Chemotherapy consisted of 3 cycles of induction with vincristine and dexamethasone, 6 cycles of consolidation alternating between methotrexate and cytarabine, and 11 cycles of maintenance with vincristine and prednisone. Chemotherapy consisted of 3 cycles of induction with vincristine and dexamethasone, 6 cycles of consolidation alternating between methotrexate and cytarabine, and 11 cycles of maintenance with vincristine and prednisone. Chemotherapy consisted of 3 cycles of induction with vincristine and dexamethasone, 6 cycles of consolidation alternating between methotrexate and cytarabine, and 11 cycles of maintenance with vincristine and prednisone. Chemotherapy consisted of 3 cycles of induction with vincristine and dexamethasone, 6 cycles of consolidation alternating between methotrexate and cytarabine, and 11 cycles of maintenance with vincristine and prednisone.FDA
Acute Lymphoblastic Leukemia, Version 2.2024, NCCN Clinical Practice… This selection from the NCCN Guidelines for ALL focuses on treatment recommendations for adults with newly diagnosed Ph-negative ALL based on current evidence. This selection from the NCCN Guidelines for ALL focuses on treatment recommendations for adults with newly diagnosed Ph-negative ALL based on current evidence. This selection from the NCCN Guidelines for ALL focuses on treatment recommendations for adults with newly diagnosed Ph-negative ALL based on current evidence. This selection from the NCCN Guidelines for ALL focuses on treatment recommendations for adults with newly diagnosed Ph-negative ALL based on current evidence. This selection from the NCCN Guidelines for ALL focuses on treatment recommendations for adults with newly diagnosed Ph-negative ALL based on current evidence.Journal of the National Comprehensive Cancer Network : JNCCN
NELARABINE (NELARABINE) Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following… Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following… Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following… Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following… Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following…Alembic Pharmaceuticals Limited
[Choice of bridging therapy prior to reinjection of autologous CAR-T… Consequently, there is currently no available guidelines. Consequently, there is currently no available guidelines. Consequently, there is currently no available guidelines. Consequently, there is currently no available guidelines. Consequently, there is currently no available guidelines.Bulletin du cancer
Clofarabine (CLOFARABINE) Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.Amneal Pharmaceuticals LLC
07

Guideline / Standard of Care

The supplied documents discuss recommendations for relapsed/refractory acute lymphoblastic leukemia (ALL), including immunotherapy, targeted therapy, transplantation, and CNS-directed therapy, but they do not provide a complete regimen-by-regimen listing organized by treatment setting, line of therapy, and guideline preference category for all patients in the United States as of 2026-09-22. The ASH 2026 guideline for adolescents and young adults (AYAs) states that recommendations "focused on the

Treatment Evidence
Ready | 8 sources |includes web evidence
Sources
FDA ESMO FDA Drug Labeling (openFDA) National Cancer Institute (NCI)
BodyGuidelineCurrent version
FDA grants accelerated approval to ponatinib with chemotherapy for ... Chemotherapy consisted of 3 cycles of induction with vincristine and dexamethasone, 6 cycles of consolidation alternating between methotrexate and cytarabine, and 11 cycles of maintenance with vincristine and prednisone.FDA
Acute Lymphoblastic Leukemia, Version 2.2024, NCCN Clinical Practice… This selection from the NCCN Guidelines for ALL focuses on treatment recommendations for adults with newly diagnosed Ph-negative ALL based on current evidence.Journal of the National Comprehensive Cancer Network : JNCCN
NELARABINE (NELARABINE) Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following…Alembic Pharmaceuticals Limited
[Choice of bridging therapy prior to reinjection of autologous CAR-T… Consequently, there is currently no available guidelines.Bulletin du cancer
Clofarabine (CLOFARABINE) Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.Amneal Pharmaceuticals LLC
08

Approved Therapy & Label Intelligence

The supplied documents identify three FDA-approved drug products for acute lymphoblastic leukemia (ALL): clofarabine, imatinib mesylate, and dasatinib. Clofarabine injection is indicated for “pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens,” with “Initial U.S. Approval: 2004.” Imatinib mesylate is indicated for “Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (

Treatment Evidence
Ready | 8 sources |includes web evidence
Sources
FDA Drug Labeling (openFDA) ESMO National Cancer Institute (NCI) FDA Drugs@FDA (openFDA)
SettingIntentGuideline-preferred regimens
FDA grants accelerated approval to ponatinib with chemotherapy for ... Chemotherapy consisted of 3 cycles of induction with vincristine and dexamethasone, 6 cycles of consolidation alternating between methotrexate and cytarabine, and 11 cycles of maintenance with vincristine and prednisone.FDA
Acute Lymphoblastic Leukemia, Version 2.2024, NCCN Clinical Practice… This selection from the NCCN Guidelines for ALL focuses on treatment recommendations for adults with newly diagnosed Ph-negative ALL based on current evidence.Journal of the National Comprehensive Cancer Network : JNCCN
NELARABINE (NELARABINE) Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following…Alembic Pharmaceuticals Limited
[Choice of bridging therapy prior to reinjection of autologous CAR-T… Consequently, there is currently no available guidelines.Bulletin du cancer
Clofarabine (CLOFARABINE) Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.Amneal Pharmaceuticals LLC
09

Key Clinical & Treatment Insights

The discovery phase established 8 findings across 2 stage report(s); the points below should inform downstream modelling.

Celestra Synthesis
Ready | 15 sources
  1. ALL is described as a rare lymphoid malignancy affecting marrow and blood with potential infiltration into any organ or tissue. Orphanet
  2. The disease burden is concentrated in children, adolescents, and young adults, with diagnoses most frequent in patients younger than 20 years. [Source: National Cancer Institute, Surveillan
  3. U.S. SEER estimates include 6,250 projected new cases and 1,600 projected deaths in 2026. National Cancer Institute, Surveillance, Epidemiology, and End Results Program
  4. The supplied documents do not provide a comprehensive list of United States first-line treatment regimens for acute lymphoblastic leukemia across induction, consolidation, maintenance, and MRD-positiv
  5. The supplied documents discuss recommendations for relapsed/refractory acute lymphoblastic leukemia (ALL), including immunotherapy, targeted therapy, transplantation, and CNS-directed therapy, but the
  6. The supplied documents identify three FDA-approved drug products for acute lymphoblastic leukemia (ALL): clofarabine, imatinib mesylate, and dasatinib. Clofarabine injection is indicated for “pediatri
Sources
CDC / NCHS Orphanet / Orphadata NCI SEER National Cancer Institute (NCI)

Source conflicts (0)

Discovery surfaced no disagreements between sources.