Nivestim
Therapy Related Acute Myeloid Leukemia And Myelodysplastic Syndrome
Floatz Rating
BBB72/100
Confidence
Indicative
Sponsor
City of Hope Medical Center
Modality
protein_peptide
Development Phase
Phase 2/3
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 |
|---|---|---|---|---|---|
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 | — | — | — |
NCT07012044CT.gov A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT06928662CT.gov Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse | — | Recruiting | — | — | — |
NCT05564390CT.gov MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) | — | Recruiting | — | — | — |
NCT05780879CT.gov A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG or CLAG) for Frontline Therapy of Secondary Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT05139004CT.gov 90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome | — | Active Not Recruiting | — | — | — |
NCT03096782CT.gov Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma | — | Completed | — | — | — |
NCT02727803CT.gov Personalized NK Cell Therapy in CBT | — | Recruiting | — | — | — |
NCT02642965CT.gov Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
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 | — | — | — |
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NCT01904136CT.gov Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous 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 | — | — | — |
NCT02044796CT.gov Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes | — | Completed | — | — | — |
NCT01619761CT.gov NK Cells in Cord Blood Transplantation | — | Unknown | — | — | — |
NCT01076270CT.gov Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies | — | Terminated | — | — | — |
NCT00462605CT.gov MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia | — | Completed | — | — | — |
NCT00209833CT.gov Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T | — | Unknown | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Therapy Related Acute Myeloid Leukemia And Myelodysplastic Syndrome
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nivestim (this asset) | City of Hope Medical Center | P2/3 | BBB · 72 |
| Daunomycin | National Cancer Institute (NCI) | P3 | BBB |
| Cytarabine | National Cancer Institute (NCI) | P3 | BBB |
| Etoposide | M.D. Anderson Cancer Center | P3 | BB |
| Idarubicin | Fred Hutchinson Cancer Center | P2/3 | BB |
| Cyclophosphamide | Fred Hutchinson Cancer Center | P3 | BB |
| Mitoxantrone | Institut de Recherches Internationales Servier | P2 | BB |
| Melphalan | City of Hope Medical Center | P2 | BB |
| 2 (1H))-QUINOLINONE,6-(AMINO(4-CHLOROPHENYL)(1-METHYL-1H-IMIDAZOL-5-YL)METHYL)-4-(3-CHLOROPHENYL)-1-METHYL-,(+)- | National Cancer Institute (NCI) | P2 | BB |
+42 more in the Therapy Related Acute Myeloid Leukemia And Myelodysplastic Syndrome cohort
Other indications for Nivestim
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Burkitt Lymphoma | — | P4 | BBB · 78 |
| Neutropenia | — | P4 | BBB · 76 |
| Mycosis Fungoides | — | P4 | BBB · 75 |
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.
Citation
Floatz Terminal. Nivestim in Therapy Related Acute Myeloid Leukemia And Myelodysplastic Syndrome. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 13, 2026. https://terminal.floatz.ai/assets/n-met-g-csf-therapy-related-acute-myeloid-leukemia-and-myelodysplastic-syndrome
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