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Disease

B-cell acute lymphoblastic leukemia

Late-stage therapeutic development

Also known as B lymphoblastic leukemia/lymphoma, precursor B lymphoblastic leukemia/lymphoma, precursor B-lymphoblastic lymphoma/leukemia, precursor B lymphoblastic lymphoma/leukemia.

18
Clinical trials
12
Associated genes
3
Related proteins
Current focus
B-cell cd22 biologyB-lymphocyte cd19 biologyTherapeutic developmentInflammation & immunity

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 4 clinical trials expected to report results, the earliest in Q1 2027.
Upcoming Milestones
Clinical Milestones6View
Results posted 1
Results expected 4
Other updates 1
Activity timeline6

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Melphalan hydrochlorideapproved

Approval — High-dose of Phelinun used alone or in combination with other cytotoxic medicinal product… (2020)

Clinical trials

15 sponsors · 3 new · 0 completed in the last 12 months (net +3)

The current development programme across all trial phases.

Clinical programme
18
All trials
6
Active
4
Late-stage
6
Completed
Late-stage studies

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Phase 2/3 · Recruiting · Merck Sharp & Dohme LLC

An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed/Refractory B-Cell Malignancies (NexCAR19)

Phase 2/3 · Recruiting · Health Institutes of Turkey

Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)

Phase 3 · Recruiting · Memorial Sloan Kettering Cancer Center

A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication

Phase 3 · Recruiting · Novartis Pharmaceuticals
Recruiting

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Phase 2/3 · Recruiting · Merck Sharp & Dohme LLC

An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed/Refractory B-Cell Malignancies (NexCAR19)

Phase 2/3 · Recruiting · Health Institutes of Turkey

Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)

Phase 3 · Recruiting · Memorial Sloan Kettering Cancer Center

Blinatumomab Combined With Reduced-dose Chemotherapy in Treating Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study

Phase 2 · Recruiting · First Affiliated Hospital of Zhejiang University

A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication

Phase 3 · Recruiting · Novartis Pharmaceuticals

Phase II Clinical Study of CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/refractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (inclusive)

Phase 2 · Recruiting · Beijing Yongtai Ruike Biotechnology Company Ltd
Recently completed

Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients with Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia

Phase 2 · Completed · Zhejiang University

A Phase I/II Study of Blinatumomab in Combination With Pembrolizumab (MK-3475) for Adults With Relapsed or Refractory B-lineage Acute Lymphoblastic Leukemia With High Bone Marrow Lymphoblast Percentage

Phase 1/2 · Completed · University of California, San Diego

A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia

Phase 1 · Completed · Institut de Recherches Internationales Servier

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia

Phase 2 · Completed · Novartis Pharmaceuticals

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia

Phase 2 · Completed · Novartis Pharmaceuticals

A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)

Phase 2 · Completed · Amgen Research (Munich) GmbH

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2020emaApproval — Melphalan hydrochloride· High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of: multiple myeloma, malignant lymphoma (Hodgkin, non-Hodgkin lymphoma), acute lymphoblastic and myeloblastic leukemia, childhood neuroblastoma, ovarian cancer, mammary adenocarcinoma. Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults. Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as: Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases RIC treatment in case of non-malignant haematological diseases. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

GATA30.54CD190.52IKZF10.50ERG0.48CD3E0.47ARID5B0.46CD220.45PIP4K2A0.43TCF30.42BAK10.42FIGNL10.40PAX50.37

Disease biology

3 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

B-lymphocyte antigen CD19via CD190.52T-cell surface glycoprotein CD3 epsilon chainvia CD3E0.47B-cell receptor CD22via CD220.45

Reference

Authoritative identity, definition & identifiers.

Synonyms

B lymphoblastic leukemia/lymphoma, precursor B lymphoblastic leukemia/lymphoma, precursor B-lymphoblastic lymphoma/leukemia, precursor B lymphoblastic lymphoma/leukemia

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.