Floatz Rating
BB68/100
Confidence
Indicative
Sponsor
University of Florida
Modality
Small molecule
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.
65High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05766514CT.gov Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction | — | Withdrawn | — | — | — |
NCT06021600CT.gov A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine | — | Terminated | — | — | — |
NCT04708054CT.gov Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS | — | Recruiting | — | — | — |
NCT04375631CT.gov CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia | — | Recruiting | — | — | — |
NCT04047641CT.gov Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT03589729CT.gov Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers | — | Recruiting | — | — | — |
NCT03150004CT.gov Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) | — | Terminated | — | — | — |
NCT02728050CT.gov Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT02921061CT.gov Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS | — | Completed | — | — | — |
NCT02756572CT.gov Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms | — | Completed | — | — | — |
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NCT02250937CT.gov Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome | — | Active Not Recruiting | — | — | — |
NCT02115295CT.gov Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia | — | 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 | — | — | — |
NCT00004904CT.gov Stem Cell Transplantation in Treating Patients With Hematologic Cancer | — | Completed | — | — | — |
NCT00002833CT.gov Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Myelodysplastic Syndrome
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Cladribine (this asset) | University of Florida | P2/3 | BB · 68 |
| Cyclophosphamide | Sawa Ito, MD | P4 | BB |
| Nivestim | City of Hope Medical Center | P4 | BB |
| Busulfanum | Sawa Ito, MD | P4 | BB |
| Daunomycin | OHSU Knight Cancer Institute | P3 | BB |
| Cytarabine | The First Affiliated Hospital of Soochow University | P4 | BB |
| Fludarabine | City of Hope Medical Center | P4 | BB |
| Idarubicin | OHSU Knight Cancer Institute | P4 | BB |
| Sitagliptin | Indiana University | P2 | BB |
+42 more in the Myelodysplastic Syndrome cohort
Other indications for Cladribine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Relapsing-Remitting Multiple Sclerosis | — | P4 | BBB · 76 |
| Lymphoblastic Lymphoma | — | P4 | BBB · 75 |
| Multiple Sclerosis | — | P4 | 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. Cladribine in Myelodysplastic Syndrome. 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/cladribine-myelodysplastic-syndrome
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