Fludarabine
B-Cell Acute Lymphoblastic Leukemia
Explore 136 assets in B-Cell Acute Lymphoblastic Leukemia →Floatz Rating
B60/100
Confidence
Indicative
Sponsor
National Cancer Institute (NCI)
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
56High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07572136CT.gov Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL) | — | Not Yet Recruiting | — | — | — |
NCT07328503CT.gov CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia | — | Recruiting | — | — | — |
NCT07166549CT.gov Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial) | — | Not Yet Recruiting | — | — | — |
NCT07523555CT.gov Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies | — | Recruiting | — | — | — |
NCT07223021CT.gov A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia | — | Recruiting | — | — | — |
NCT06009107CT.gov A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL) | — | Withdrawn | — | — | — |
NCT06777979CT.gov CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia | — | Recruiting | — | — | — |
NCT07564453CT.gov Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia | — | Recruiting | — | — | — |
NCT06879340CT.gov Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies | — | Recruiting | — | — | — |
NCT06208735CT.gov CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies | — | Recruiting | — | — | — |
Show 38 more trialsShow fewer
NCT06514768CT.gov JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL) | — | Recruiting | — | — | — |
NCT06253663CT.gov Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
NCT06056752CT.gov QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia | — | Recruiting | — | — | — |
NCT05320380CT.gov A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat | — | Withdrawn | — | — | — |
NCT05707273CT.gov CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission | — | Active Not Recruiting | — | — | — |
NCT05310591CT.gov Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence | — | Recruiting | — | — | — |
NCT05442515CT.gov CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies | — | Recruiting | — | — | — |
NCT05418088CT.gov Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies | — | Recruiting | — | — | — |
NCT05350852CT.gov Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD+ B-ALL | — | Unknown | — | — | — |
NCT05350787CT.gov Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With R/R B-ALL | — | Completed | — | — | — |
NCT05379647CT.gov Natural Killer (NK) Cell Therapy for B-Cell Malignancies | — | Unknown | — | — | — |
NCT04653493CT.gov CD19 Targeted CAR T Cell Therapy in Patients With Relapsed/ Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) | — | Unknown | — | — | — |
NCT04836507CT.gov Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients | — | Recruiting | — | — | — |
NCT04844086CT.gov RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies | — | Terminated | — | — | — |
NCT05513612CT.gov Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies | — | Withdrawn | — | — | — |
NCT04318678CT.gov CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML) | — | Recruiting | — | — | — |
NCT03579888CT.gov CD19-Specific T Cells Post AlloSCT | — | Terminated | — | — | — |
NCT04264039CT.gov Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies | — | Unknown | — | — | — |
NCT04260945CT.gov CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients | — | Completed | — | — | — |
NCT03856216CT.gov Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation | — | Terminated | — | — | — |
NCT04088890CT.gov Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies | — | Completed | — | — | — |
NCT04191941CT.gov Treatment of Hematological Malignancy With Novel CAR-T Cells. | — | Unknown | — | — | — |
NCT04029038CT.gov Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma | — | Withdrawn | — | — | — |
NCT03666000CT.gov Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) | — | Recruiting | — | — | — |
NCT03509961CT.gov The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL | — | Recruiting | — | — | — |
NCT03467256CT.gov CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL | — | Unknown | — | — | — |
NCT03448393CT.gov CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies | — | Completed | — | — | — |
NCT03103971CT.gov huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia | — | Terminated | — | — | — |
NCT03241940CT.gov Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults w/ Recurrent or Refractory B Cell Malignancies | — | Active Not Recruiting | — | — | — |
NCT03233854CT.gov CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies | — | Active Not Recruiting | — | — | — |
NCT03263208CT.gov CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL. | — | Unknown | — | — | — |
NCT02924753CT.gov The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL). | — | Unknown | — | — | — |
NCT02625480CT.gov Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma | — | Completed | — | — | — |
NCT01974479CT.gov Pilot Study of Redirected Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia | — | Suspended | — | — | — |
NCT01256398CT.gov Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00864227CT.gov Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604) | — | Completed | — | — | — |
NCT00849147CT.gov Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603) | — | Completed | — | — | — |
NCT00036738CT.gov Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · B-Cell Acute Lymphoblastic Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Fludarabine (this asset) | National Cancer Institute (NCI) | P3 | B · 60 |
| Etoposide | University of Washington | P3 | BBB |
| Vincristine Sulfate | City of Hope Medical Center | P3 | BB |
| Crisantaspase | City of Hope Medical Center | P3 | BB |
| Pegaspargase | National Cancer Institute (NCI) | P3 | BB |
| Nivestim | University of Washington | P3 | BB |
| Dasatinib | National Cancer Institute (NCI) | P3 | BB |
| Mercaptopurine Anhydrous | SWOG Cancer Research Network | P3 | BB |
| Cyclophosphamide | SWOG Cancer Research Network | P3 | BB |
+42 more in the B-Cell Acute Lymphoblastic Leukemia cohort
Other indications for Fludarabine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Adult T-Cell Leukemia/Lymphoma | — | P2 | BBB · 76 |
| Acute Myeloid Leukemia With Abnormal Bone Marrow Eosinophils Inv(16)(P13q22) Or T(16;16)(P13;Q22) | — | P2 | BBB · 76 |
| Fanconi Anemia | — | P2/3 | BBB · 76 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Fludarabine in B-Cell Acute Lymphoblastic Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 11, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/fludarabine-b-cell-acute-lymphoblastic-leukemia
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