Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
Guenther Koehne
Modality
protein_peptide
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
66High 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 | — | — | — |
NCT07258043CT.gov Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia | — | 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 | — | — | — |
NCT06815003CT.gov Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning | — | Recruiting | — | — | — |
NCT06059391CT.gov CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant | — | 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 | — | — | — |
NCT06001385CT.gov HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis | — | Active Not Recruiting | — | — | — |
NCT05735717CT.gov MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies | — | 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 | — | — | — |
NCT04282174CT.gov CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies | — | Withdrawn | — | — | — |
Show 52 more trialsShow fewer
NCT05170828CT.gov Cryopreserved MMUD BM With PTCy for Hematologic Malignancies | — | Withdrawn | — | — | — |
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 | — | — | — |
NCT04904588CT.gov HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide | — | Active Not 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 | — | — | — |
NCT04752163CT.gov DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia | — | Terminated | — | — | — |
NCT04195633CT.gov Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies | — | Recruiting | — | — | — |
NCT04473911CT.gov Haplo Peripheral Blood Sct In GVHD Prevention | — | Completed | — | — | — |
NCT03856216CT.gov Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation | — | Terminated | — | — | — |
NCT03860844CT.gov Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia | — | Terminated | — | — | — |
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 | — | — | — |
NCT03674411CT.gov Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy | — | Active Not Recruiting | — | — | — |
NCT03821610CT.gov A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC) | — | Active Not Recruiting | — | — | — |
NCT03615105CT.gov Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors | — | Terminated | — | — | — |
NCT03147612CT.gov Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
NCT03434730CT.gov Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation | — | Completed | — | — | — |
NCT03096782CT.gov Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma | — | Completed | — | — | — |
NCT03007147CT.gov Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
NCT02793544CT.gov HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide | — | Completed | — | — | — |
NCT02933333CT.gov G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor | — | Unknown | — | — | — |
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 | — | — | — |
NCT02750254CT.gov Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation | — | Terminated | — | — | — |
NCT02727803CT.gov Personalized NK Cell Therapy in CBT | — | Recruiting | — | — | — |
NCT03318419CT.gov Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia | — | Unknown | — | — | — |
NCT02593123CT.gov Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis | — | Completed | — | — | — |
NCT02259348CT.gov Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation | — | Terminated | — | — | — |
NCT01619761CT.gov NK Cells in Cord Blood Transplantation | — | Unknown | — | — | — |
NCT01685411CT.gov Busulfan and Cyclophosphamide Followed By ALLO BMT | — | Terminated | — | — | — |
NCT01745913CT.gov Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for Hematologic Malignancies | — | Terminated | — | — | — |
NCT01564784CT.gov A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00686556CT.gov Total Marrow Irradiation for Refractory Acute Leukemia | — | Completed | — | — | — |
NCT01572662CT.gov Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning | — | Completed | — | — | — |
NCT01540812CT.gov Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS | — | Completed | — | — | — |
NCT01500161CT.gov Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match | — | Terminated | — | — | — |
NCT01297543CT.gov Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia | — | Completed | — | — | — |
NCT01256398CT.gov Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | — | 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 | — | — | — |
NCT00968253CT.gov RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia | — | Completed | — | — | — |
NCT00916045CT.gov Pilot Study of Unrelated Cord Blood Transplantation | — | Terminated | — | — | — |
NCT00792948CT.gov Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
NCT01050764CT.gov Haploidentical Allogeneic Transplant With Post-transplant Infusion of Regulatory T-cells | — | Terminated | — | — | — |
NCT00720109CT.gov Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00557193CT.gov Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00566696CT.gov Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies | — | Completed | — | — | — |
NCT00773149CT.gov Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia | — | Completed | — | — | — |
NCT00133367CT.gov Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus | — | Completed | — | — | — |
NCT00890656CT.gov Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage | — | Completed | — | — | — |
NCT00067002CT.gov Randomized Double Cord Blood Transplant Study | — | Completed | — | — | — |
NCT00671658CT.gov Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00516152CT.gov Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT | — | Completed | — | — | — |
NCT00571662CT.gov Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant | — | Completed | — | — | — |
NCT00176839CT.gov Stem Cell Transplantation for Hematological Malignancies | — | Terminated | — | — | — |
NCT00636909CT.gov Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders | — | 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 |
|---|---|---|---|
| Nivestim (this asset) | Guenther Koehne | Approved | BB · 66 |
| Gm-Csf | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | P4 | BBB |
| Peripheral Blood Stem Cells, Allogeneic, Cd34 Positive | Fred Hutchinson Cancer Center | P2/3 | BBB |
| Equine Atg | Instituto Nacional de Cancer, Brazil | P3 | BBB |
| Thioguanine Anhydrous | St. Jude Children's Research Hospital | P4 | BBB |
| Daunomycin | PETHEMA Foundation | P4 | BB |
| Pegaspargase | Dana-Farber Cancer Institute | P4 | BB |
| Methotrexate | Princess Maxima Center for Pediatric Oncology | P4 | BB |
| Asparaginase | Centre Hospitalier Universitaire de Nice | P4 | BB |
+42 more in the Acute Lymphoblastic Leukemia 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.
Related assets
- Gm-CsfXinhua Hospital, Shanghai Jiao Tong University School of MedicineBBB
- Peripheral Blood Stem Cells, Allogeneic, Cd34 PositiveFred Hutchinson Cancer CenterBBB
- Equine AtgInstituto Nacional de Cancer, BrazilBBB
- Thioguanine AnhydrousSt. Jude Children's Research HospitalBBB
- DaunomycinPETHEMA FoundationBB
Citation
Floatz Terminal. Nivestim 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/n-met-g-csf-acute-lymphoblastic-leukemia
Are you the sponsor?
Submit your data room for a Verified Rating. The public-data rating remains visible alongside.
Contact →