Floatz Rating
B63/100
Confidence
Indicative
Sponsor
Sawa Ito, MD
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
63High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05565105CT.gov CD34+ Transplants for Leukemia and Lymphoma | — | Not Yet Recruiting | — | — | — |
NCT07575412CT.gov SHR2554/AZA + Overlapped Modified BUCY for High-risk/Relapsed Leukemia/MDS | — | Not Yet Recruiting | — | — | — |
NCT07565220CT.gov Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies | — | Not Yet Recruiting | — | — | — |
NCT07562568CT.gov SHR2554/AZA + Overlapped TBF for High-risk/Relapsed Leukemia/MDS | — | Not Yet Recruiting | — | — | — |
NCT07020533CT.gov A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant | — | Recruiting | — | — | — |
NCT07566377CT.gov Cord Blood Transplantation in Children and Young Adults With Blood Cancer | — | Recruiting | — | — | — |
NCT06859424CT.gov A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation | — | Recruiting | — | — | — |
NCT06680661CT.gov ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis | — | Recruiting | — | — | — |
NCT06816134CT.gov Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia | — | Recruiting | — | — | — |
NCT06013423CT.gov Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases | — | Recruiting | — | — | — |
Show 56 more trialsShow fewer
NCT06195891CT.gov Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT06001385CT.gov HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis | — | Active Not Recruiting | — | — | — |
NCT05735717CT.gov MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies | — | Recruiting | — | — | — |
NCT05457556CT.gov Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome | — | Active Not Recruiting | — | — | — |
NCT04083170CT.gov Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers | — | Terminated | — | — | — |
NCT05170828CT.gov Cryopreserved MMUD BM With PTCy for Hematologic Malignancies | — | Withdrawn | — | — | — |
NCT04282174CT.gov CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies | — | Withdrawn | — | — | — |
NCT03399773CT.gov Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes | — | Active Not Recruiting | — | — | — |
NCT04904588CT.gov HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide | — | Active Not Recruiting | — | — | — |
NCT04872595CT.gov A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant | — | Active Not Recruiting | — | — | — |
NCT04942730CT.gov Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe) | — | Completed | — | — | — |
NCT04644016CT.gov Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders | — | Recruiting | — | — | — |
NCT04151706CT.gov CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML | — | Completed | — | — | — |
NCT03970096CT.gov Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) | — | Recruiting | — | — | — |
NCT03779854CT.gov Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant | — | Recruiting | — | — | — |
NCT03885947CT.gov VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies | — | Completed | — | — | — |
NCT03849651CT.gov TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies | — | Active Not Recruiting | — | — | — |
NCT03674411CT.gov Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy | — | Active Not Recruiting | — | — | — |
NCT03615105CT.gov Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors | — | Terminated | — | — | — |
NCT03235973CT.gov Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes | — | Unknown | — | — | — |
NCT03314974CT.gov Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders | — | Recruiting | — | — | — |
NCT03096782CT.gov Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma | — | Completed | — | — | — |
NCT02793544CT.gov HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide | — | Completed | — | — | — |
NCT02861417CT.gov Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant | — | Active Not Recruiting | — | — | — |
NCT02790515CT.gov Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation | — | Active Not Recruiting | — | — | — |
NCT02750254CT.gov Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation | — | Terminated | — | — | — |
NCT02799147CT.gov GVHD Prophylaxis With Post-transplantation Bendamustine in Refractory Leukemia | — | Completed | — | — | — |
NCT02727803CT.gov Personalized NK Cell Therapy in CBT | — | Recruiting | — | — | — |
NCT02220985CT.gov Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD | — | Completed | — | — | — |
NCT02294552CT.gov Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT | — | Completed | — | — | — |
NCT02259348CT.gov Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation | — | Terminated | — | — | — |
NCT02083250CT.gov Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission or Relapse Undergoing Donor Stem Cell Transplant | — | Completed | — | — | — |
NCT02605460CT.gov Chemo Sensitization Before Hematopoietic Stem Cell Transplantation in Patients With Acute Leukemia in Complete Remission | — | Unknown | — | — | — |
NCT01685411CT.gov Busulfan and Cyclophosphamide Followed By ALLO BMT | — | Terminated | — | — | — |
NCT01690520CT.gov Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes | — | Completed | — | — | — |
NCT01621477CT.gov T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant | — | Terminated | — | — | — |
NCT01643668CT.gov Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation | — | Completed | — | — | — |
NCT01572662CT.gov Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning | — | Completed | — | — | — |
NCT01500161CT.gov Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match | — | Terminated | — | — | — |
NCT01119066CT.gov HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies | — | Completed | — | — | — |
NCT01025778CT.gov Haploidentical Stem Cell Transplantation for Children With Therapy Resistant Leukemia | — | Completed | — | — | — |
NCT00863148CT.gov Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL) | — | Completed | — | — | — |
NCT00990249CT.gov Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation | — | Completed | — | — | — |
NCT00916045CT.gov Pilot Study of Unrelated Cord Blood Transplantation | — | Terminated | — | — | — |
NCT01050946CT.gov Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit | — | Terminated | — | — | — |
NCT01050764CT.gov Haploidentical Allogeneic Transplant With Post-transplant Infusion of Regulatory T-cells | — | Terminated | — | — | — |
NCT00815568CT.gov Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI) | — | Unknown | — | — | — |
NCT00593554CT.gov Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies | — | Terminated | — | — | — |
NCT00579111CT.gov Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB) | — | Terminated | — | — | — |
NCT00619879CT.gov Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies | — | Completed | — | — | — |
NCT00458250CT.gov Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H | — | Completed | — | — | — |
NCT00719888CT.gov Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease | — | Completed | — | — | — |
NCT00067002CT.gov Randomized Double Cord Blood Transplant Study | — | Completed | — | — | — |
NCT00516152CT.gov Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT | — | Completed | — | — | — |
NCT00176930CT.gov Stem Cell Transplant for Hematological Malignancy | — | Terminated | — | — | — |
NCT00176839CT.gov Stem Cell Transplantation for Hematological Malignancies | — | Terminated | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Lymphoblastic Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Busulfanum (this asset) | Sawa Ito, MD | Approved | B · 63 |
| Peripheral Blood Stem Cells, Allogeneic, Cd34 Positive | Fred Hutchinson Cancer Center | P2/3 | BBB |
| Gm-Csf | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | P4 | BBB |
| Thioguanine Anhydrous | St. Jude Children's Research Hospital | P4 | BBB |
| Equine Atg | Instituto Nacional de Cancer, Brazil | P3 | BBB |
| Mercaptopurine Anhydrous | Dana-Farber Cancer Institute | P4 | BB |
| Methotrexate | Princess Maxima Center for Pediatric Oncology | P4 | BB |
| Cyclophosphamide | Sawa Ito, MD | P4 | BB |
| Vincristine Sulfate | Children's Oncology Group | P3 | BB |
+42 more in the Acute Lymphoblastic Leukemia cohort
Other indications for Busulfanum
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Myelodysplastic/Myeloproliferative Neoplasm | — | P2/3 | BBB · 76 |
| Graft Versus Host Disease | — | P4 | BBB · 74 |
| Disease Related To Hematopoietic Stem Cell Transplant | — | P3 | BBB · 74 |
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
- Peripheral Blood Stem Cells, Allogeneic, Cd34 PositiveFred Hutchinson Cancer CenterBBB
- Gm-CsfXinhua Hospital, Shanghai Jiao Tong University School of MedicineBBB
- Thioguanine AnhydrousSt. Jude Children's Research HospitalBBB
- Equine AtgInstituto Nacional de Cancer, BrazilBBB
- Mercaptopurine AnhydrousDana-Farber Cancer InstituteBB
Citation
Floatz Terminal. Busulfanum in Acute Lymphoblastic Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 9, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/busulfanum-acute-lymphoblastic-leukemia
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