Floatz Rating
B61/100
Confidence
Indicative
Sponsor
City of Hope Medical Center
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.
62High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07582172CT.gov Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome | — | Not Yet Recruiting | — | — | — |
NCT07366801CT.gov Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies | — | Recruiting | — | — | — |
NCT06287944CT.gov 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT05805605CT.gov Allo HSCT Using RIC and PTCy for Hematological Diseases | — | Recruiting | — | — | — |
NCT05170828CT.gov Cryopreserved MMUD BM With PTCy for Hematologic Malignancies | — | Withdrawn | — | — | — |
NCT05105152CT.gov PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML | — | Recruiting | — | — | — |
NCT04888741CT.gov Methods of T Cell Depletion Trial (MoTD) | — | Recruiting | — | — | — |
NCT04473911CT.gov Haplo Peripheral Blood Sct In GVHD Prevention | — | Completed | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT03970096CT.gov Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) | — | Recruiting | — | — | — |
Show 20 more trialsShow fewer
NCT03246906CT.gov Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation | — | Terminated | — | — | — |
NCT03192397CT.gov Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant | — | Active Not Recruiting | — | — | — |
NCT02722668CT.gov UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep | — | Completed | — | — | — |
NCT02793544CT.gov HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide | — | Completed | — | — | — |
NCT02756572CT.gov Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms | — | Completed | — | — | — |
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 | — | — | — |
NCT02728700CT.gov Sirolimus and Mycophenolate Mofetil in Preventing GVHD in Patients With Hematologic Malignancies Undergoing HSCT | — | Terminated | — | — | — |
NCT02528877CT.gov Ruxolitinib Phosphate, Tacrolimus and Sirolimus in Preventing Acute Graft-versus-Host Disease During Reduced Intensity Donor Hematopoietic Cell Transplant in Patients With Myelofibrosis | — | Withdrawn | — | — | — |
NCT02583893CT.gov Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01885689CT.gov Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia | — | Active Not Recruiting | — | — | — |
NCT01869114CT.gov Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy | — | Completed | — | — | — |
NCT01231412CT.gov Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant | — | Completed | — | — | — |
NCT01184898CT.gov Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML) | — | Completed | — | — | — |
NCT00861874CT.gov A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00634244CT.gov Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00780104CT.gov Sirolimus in Combination With MEC in High Risk Myeloid Leukemias | — | Completed | — | — | — |
NCT00406393CT.gov Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402) | — | Completed | — | — | — |
NCT00235560CT.gov Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients | — | Completed | — | — | — |
NCT00105001CT.gov Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer | — | Completed | — | — | — |
NCT00144677CT.gov Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation | — | 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 |
|---|---|---|---|
| Sirolimus (this asset) | City of Hope Medical Center | P3 | B · 61 |
| 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 Sirolimus
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Tuberous Sclerosis | — | P3 | BBB · 73 |
| Disease Related To Transplantation | — | P4 | BBB · 72 |
| Myelodysplastic/Myeloproliferative Neoplasm | — | P2 | BB · 69 |
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. Sirolimus 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/sirolimus-acute-myeloid-leukemia
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