Floatz Rating
B63/100
Confidence
Indicative
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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 |
|---|---|---|---|---|---|
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NCT05170828CT.gov Cryopreserved MMUD BM With PTCy for Hematologic Malignancies | — | Withdrawn | — | — | — |
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 | — | — | — |
NCT03246906CT.gov Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation | — | Terminated | — | — | — |
NCT02722668CT.gov UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep | — | Completed | — | — | — |
Show 14 more trialsShow fewer
NCT02793544CT.gov HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide | — | 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 | — | — | — |
NCT01658007CT.gov Pilot Study Of Sirolimus Plus Multiagent Chemotherapy For Relapsed/Refractory Acute Lymphoblastic Leukemia/Lymphoma | — | Terminated | — | — | — |
NCT01231412CT.gov Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant | — | Completed | — | — | — |
NCT01184885CT.gov A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy | — | Completed | — | — | — |
NCT00792948CT.gov Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
NCT00957320CT.gov Study of Sirolimus With PEG-Asparaginase in Acute Lymphoblastic Leukemia (ALL) | — | Withdrawn | — | — | — |
NCT00874562CT.gov Rapamycin in Relapsed Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00776373CT.gov Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies | — | Terminated | — | — | — |
NCT00406393CT.gov Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402) | — | Completed | — | — | — |
NCT00795886CT.gov Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL) | — | Completed | — | — | — |
NCT00133367CT.gov Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus | — | Completed | — | — | — |
NCT00144677CT.gov Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation | — | Completed | — | — | — |
NCT00144703CT.gov Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation | — | Completed | — | — | — |
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 |
|---|---|---|---|
| Sirolimus (this asset) | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | P3 | 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 |
| Asparaginase | Centre Hospitalier Universitaire de Nice | P4 | BB |
| Daunomycin | PETHEMA Foundation | P4 | BB |
| Pegaspargase | Dana-Farber Cancer Institute | P4 | BB |
+42 more in the Acute Lymphoblastic 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
- 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. Sirolimus in Acute Lymphoblastic 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-lymphoblastic-leukemia
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