Floatz Rating
BB67/100
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.
68High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07524530CT.gov Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers | — | Not Yet Recruiting | — | — | — |
NCT07566377CT.gov Cord Blood Transplantation in Children and Young Adults With Blood Cancer | — | Recruiting | — | — | — |
NCT02441803CT.gov Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT01471067CT.gov Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies | — | Completed | — | — | — |
NCT01572662CT.gov Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning | — | Completed | — | — | — |
NCT00943319CT.gov Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies | — | Completed | — | — | — |
NCT01471444CT.gov Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) | — | Completed | — | — | — |
NCT00448201CT.gov Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease | — | Completed | — | — | — |
NCT01118013CT.gov Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant | — | Terminated | — | — | — |
NCT00963274CT.gov Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | — | Completed | — | — | — |
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NCT01027000CT.gov Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | — | Completed | — | — | — |
NCT00990249CT.gov Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation | — | Completed | — | — | — |
NCT00857389CT.gov Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies | — | Completed | — | — | — |
NCT00822770CT.gov Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin | — | Completed | — | — | — |
NCT00840684CT.gov Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00513474CT.gov Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant | — | Completed | — | — | — |
NCT00801931CT.gov Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders | — | Terminated | — | — | — |
NCT00498316CT.gov Cord Blood Expansion on Mesenchymal Stem Cells | — | Completed | — | — | — |
NCT00410982CT.gov Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies | — | Completed | — | — | — |
NCT00454480CT.gov Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes | — | Completed | — | — | — |
NCT00630565CT.gov Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT00402558CT.gov Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) | — | Completed | — | — | — |
NCT00448357CT.gov Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen | — | Completed | — | — | — |
NCT00245037CT.gov Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer | — | Completed | — | — | — |
NCT00295997CT.gov Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia | — | Unknown | — | — | — |
NCT00114257CT.gov Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders | — | Completed | — | — | — |
NCT00818961CT.gov Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer | — | Terminated | — | — | — |
NCT00301951CT.gov Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer | — | Completed | — | — | — |
NCT00070174CT.gov Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy | — | Completed | — | — | — |
NCT00077116CT.gov Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT00049517CT.gov Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia | — | Completed | — | — | — |
NCT00053196CT.gov Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer | — | Completed | — | — | — |
NCT00304018CT.gov Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer | — | Completed | — | — | — |
NCT00042822CT.gov FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma | — | Completed | — | — | — |
NCT00024180CT.gov FR901228 in Treating Patients With Hematologic Cancer | — | Completed | — | — | — |
NCT00544115CT.gov Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders | — | Active Not Recruiting | — | — | — |
NCT00534469CT.gov Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R | — | Completed | — | — | — |
NCT00612716CT.gov Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia | — | Completed | — | — | — |
NCT00004128CT.gov Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT00008190CT.gov Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia | — | Completed | — | — | — |
NCT00296023CT.gov Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer | — | Completed | — | — | — |
NCT00003816CT.gov Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer | — | Completed | — | — | — |
NCT00003619CT.gov Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia | — | Completed | — | — | — |
NCT00002989CT.gov Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome | — | Unknown | — | — | — |
NCT00002701CT.gov Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia | — | Unknown | — | — | — |
NCT00002961CT.gov Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia | — | Terminated | — | — | — |
NCT00002549CT.gov Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia | — | Unknown | — | — | — |
NCT00060255CT.gov High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors | — | Completed | — | — | — |
NCT00081055CT.gov OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies | — | Withdrawn | — | — | — |
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 · Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Romidepsin (this asset) | National Cancer Institute (NCI) | P3 | BB · 67 |
| Vincristine Sulfate | Inhye Ahn | P3 | BB |
| Cyclophosphamide | National Cancer Institute (NCI) | P4 | BB |
| Daunomycin | Richard Stone, MD | P3 | BB |
| Pegaspargase | Dana-Farber Cancer Institute | P3 | BB |
| Busulfanum | National Cancer Institute (NCI) | P4 | BB |
| Thioguanine Anhydrous | Incyte Corporation | P3 | BB |
| Idarubicin | Affiliated Hospital of Nantong University | P3 | BB |
| Nivestim | Hospital General de Mexico | P4 | BB |
+42 more in the Leukemia cohort
Other indications for Romidepsin
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Burkitt Lymphoma | — | P2 | BBB · 73 |
| Follicular Lymphoma | — | P2 | BBB · 73 |
| Peripheral T-Cell Lymphoma, Not Otherwise Specified | — | 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. Romidepsin in 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/romidepsin-leukemia
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