Floatz Rating
BB67/100
Confidence
Indicative
Sponsor
M.D. Anderson Cancer Center
Modality
Small molecule
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.
73High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07053020CT.gov A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML) | — | Not Yet Recruiting | — | — | — |
NCT07423104CT.gov A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloid Leukemia | — | Not Yet Recruiting | — | — | — |
NCT07172204CT.gov Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML | — | Recruiting | — | — | — |
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(HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction | — | Withdrawn | — | — | — |
NCT06561152CT.gov Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML | — | Recruiting | — | — | — |
NCT06763666CT.gov CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML | — | Not Yet Recruiting | — | — | — |
NCT06504459CT.gov Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML | — | Recruiting | — | — | — |
NCT06660368CT.gov BCL2i CLAG-M in R/R Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT06007911CT.gov Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia | — | Withdrawn | — | — | — |
NCT06232655CT.gov Cladribine Venetoclax in Monocytic AML | — | Recruiting | — | — | — |
Show 42 more trialsShow fewer
NCT06133556CT.gov Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML | — | Not Yet Recruiting | — | — | — |
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 | — | — | — |
NCT05875649CT.gov A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure | — | Not Yet Recruiting | — | — | — |
NCT05330377CT.gov GM-CLAG in Relapsed/Refractory FLT3-mutated AML | — | Withdrawn | — | — | — |
NCT05657639CT.gov CAV Regimen for R/R AML | — | Recruiting | — | — | — |
NCT04797767CT.gov Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms | — | Recruiting | — | — | — |
NCT04708054CT.gov Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS | — | Recruiting | — | — | — |
NCT05053425CT.gov Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML | — | Unknown | — | — | — |
NCT05330364CT.gov Study of Chidamide Combined With Cladribine in Refractory/Relapsed Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT04254640CT.gov Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML | — | Unknown | — | — | — |
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 | — | — | — |
NCT04195945CT.gov CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients | — | Active Not Recruiting | — | — | — |
NCT04196010CT.gov Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms | — | Terminated | — | — | — |
NCT03926624CT.gov Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage | — | Terminated | — | — | — |
NCT04050280CT.gov CLAG-GO for Patients With Persistent, Relapsed or Refractory AML | — | 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 | — | — | — |
NCT03491579CT.gov Epacadostat, Cladribine and Cytarabine (ECC) in AML | — | Withdrawn | — | — | — |
NCT03586609CT.gov Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT03589729CT.gov Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers | — | Recruiting | — | — | — |
NCT03531918CT.gov Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm | — | Completed | — | — | — |
NCT03441048CT.gov Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03235973CT.gov Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes | — | Unknown | — | — | — |
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 | — | — | — |
NCT03012672CT.gov Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm | — | Completed | — | — | — |
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 | — | — | — |
NCT03384212CT.gov CBA Versus FBA Conditioning Followed by Allogeneic HSCT in Treatment of High Risk and Refractory AML | — | Unknown | — | — | — |
NCT03384225CT.gov CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML | — | Unknown | — | — | — |
NCT02676856CT.gov Hematopoietic Stem Cell Microtransplantation for in AML | — | Unknown | — | — | — |
NCT03181815CT.gov Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT02416908CT.gov Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02323022CT.gov Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
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 | — | — | — |
NCT02072811CT.gov Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia | — | Unknown | — | — | — |
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 | — | — | — |
NCT01161550CT.gov Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML | — | Completed | — | — | — |
NCT01147939CT.gov Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML) | — | Completed | — | — | — |
NCT00594555CT.gov A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia | — | Withdrawn | — | — | — |
NCT00126321CT.gov Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML) | — | Unknown | — | — | — |
NCT00136084CT.gov Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Cladribine (this asset) | M.D. Anderson Cancer Center | Approved | BB · 67 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia 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 Acute Myeloid 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/cladribine-acute-myeloid-leukemia
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