Floatz Rating
BB64/100
Confidence
Indicative
Sponsor
Sawa Ito, MD
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.
67High 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 | — | — | — |
NCT07565220CT.gov Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies | — | Not Yet Recruiting | — | — | — |
NCT07563920CT.gov TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission | — | Not Yet Recruiting | — | — | — |
NCT07566377CT.gov Cord Blood Transplantation in Children and Young Adults With Blood Cancer | — | Recruiting | — | — | — |
NCT07493538CT.gov MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases | — | Recruiting | — | — | — |
NCT06869265CT.gov Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT06680661CT.gov ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis | — | Recruiting | — | — | — |
NCT06158828CT.gov Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML | — | Recruiting | — | — | — |
NCT06013423CT.gov Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases | — | Recruiting | — | — | — |
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 | — | — | — |
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NCT05534620CT.gov Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics | — | Completed | — | — | — |
NCT04994808CT.gov Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia | — | Active Not 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 | — | — | — |
NCT04282174CT.gov CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies | — | Withdrawn | — | — | — |
NCT04708054CT.gov Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS | — | 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 | — | — | — |
NCT04195633CT.gov Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies | — | Recruiting | — | — | — |
NCT04678401CT.gov IS-free Treg HaploHCT | — | Recruiting | — | — | — |
NCT04151706CT.gov CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML | — | Completed | — | — | — |
NCT04217278CT.gov A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT | — | Active Not Recruiting | — | — | — |
NCT03970096CT.gov Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) | — | Recruiting | — | — | — |
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 | — | — | — |
NCT03615105CT.gov Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors | — | Terminated | — | — | — |
NCT03035422CT.gov Sequential Conditioning in Haploidentical Transplantation for Refractory Acute Myeloid Leukemia | — | 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 | — | — | — |
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 | — | — | — |
NCT02333058CT.gov Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies | — | Completed | — | — | — |
NCT02259348CT.gov Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation | — | Terminated | — | — | — |
NCT01858740CT.gov Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children | — | Completed | — | — | — |
NCT01894477CT.gov Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT01772953CT.gov Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT | — | Completed | — | — | — |
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 | — | — | — |
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 | — | — | — |
NCT00916045CT.gov Pilot Study of Unrelated Cord Blood Transplantation | — | Terminated | — | — | — |
NCT01050764CT.gov Haploidentical Allogeneic Transplant With Post-transplant Infusion of Regulatory T-cells | — | Terminated | — | — | — |
NCT00961142CT.gov Haploidentical Stem Cell Transplantation With CD3/CD19 Depletion and Reduced Intensity Conditioning in Patients With Acute Leukemia | — | Terminated | — | — | — |
NCT00796068CT.gov Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant | — | Completed | — | — | — |
NCT03961919CT.gov Phase II Trial in Elderly Patients With AML or MDS in Complete Remission Not Eligible for Allogenic Transplant | — | Completed | — | — | — |
NCT00860574CT.gov Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00822393CT.gov Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC) | — | Completed | — | — | — |
NCT00566696CT.gov Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies | — | Completed | — | — | — |
NCT00593554CT.gov Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies | — | Terminated | — | — | — |
NCT00491634CT.gov Treosulfan-based Conditioning for Transplantation in AML/MDS | — | Completed | — | — | — |
NCT00536601CT.gov High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors | — | Completed | — | — | — |
NCT00719888CT.gov Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease | — | Completed | — | — | — |
NCT01063660CT.gov Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML) | — | Completed | — | — | — |
NCT00067002CT.gov Randomized Double Cord Blood Transplant Study | — | Completed | — | — | — |
NCT00186823CT.gov Haploidentical Stem Cell Transplantation for Patients With Hematologic Malignancies | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Thiotepa (this asset) | Sawa Ito, MD | P3 | BB · 64 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Thiotepa
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Graft Versus Host Disease | — | P4 | BBB · 73 |
| Myelodysplastic/Myeloproliferative Neoplasm | — | P2/3 | BBB · 72 |
| Juvenile Myelomonocytic Leukemia | — | P3 | BBB · 72 |
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. Thiotepa in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/thiotepa-acute-myeloid-leukemia
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