Floatz Rating
BB67/100
Confidence
Indicative
Sponsor
German Cancer Research Center
Modality
antibody_drug_conjugate
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
71High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05662904CT.gov Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with AML | — | Not Yet Recruiting | — | — | — |
NCT07259707CT.gov Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML | — | 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 | — | — | — |
NCT05904106CT.gov Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML | — | Recruiting | — | — | — |
NCT05716009CT.gov Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML | — | Active Not Recruiting | — | — | — |
NCT05955261CT.gov A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia | — | Suspended | — | — | — |
NCT05199051CT.gov A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML | — | Active Not Recruiting | — | — | — |
NCT05558124CT.gov CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML | — | Recruiting | — | — | — |
NCT05183035CT.gov Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) | — | Recruiting | — | — | — |
NCT04915612CT.gov Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
Show 49 more trialsShow fewer
NCT04093505CT.gov Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia) | — | Terminated | — | — | — |
NCT04207190CT.gov Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT04168502CT.gov Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML | — | Recruiting | — | — | — |
NCT04385290CT.gov Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC) | — | Recruiting | — | — | — |
NCT04293562CT.gov A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations | — | Recruiting | — | — | — |
NCT04337138CT.gov A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World | — | Completed | — | — | — |
NCT04326439CT.gov AflacLL1901 (CHOA-AML) | — | Terminated | — | — | — |
NCT03374332CT.gov Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT04050280CT.gov CLAG-GO for Patients With Persistent, Relapsed or Refractory AML | — | Recruiting | — | — | — |
NCT04173585CT.gov TEAM-Trial: Targeting Epigenetic Therapy Resistance in AML With Bortezomib | — | Completed | — | — | — |
NCT04070768CT.gov Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 | — | Completed | — | — | — |
NCT03878927CT.gov CPX-351+GO in Subjects 55 Years Old, or Older, With AML | — | Terminated | — | — | — |
NCT03904251CT.gov CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT03900949CT.gov Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03839446CT.gov Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy | — | Completed | — | — | — |
NCT03737955CT.gov Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT03672539CT.gov Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome | — | Active Not 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 | — | — | — |
NCT03568994CT.gov Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT03390296CT.gov OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03287128CT.gov Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg® | — | Unknown | — | — | — |
NCT02724163CT.gov International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia | — | Recruiting | — | — | — |
NCT02473146CT.gov Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4 | — | Completed | — | — | — |
NCT01548911CT.gov Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia | — | Withdrawn | — | — | — |
NCT02117297CT.gov SCT Plus Immune Therapy in Average Risk AML/MDS | — | Completed | — | — | — |
NCT02221310CT.gov Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS | — | Completed | — | — | — |
NCT00893399CT.gov Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation | — | Completed | — | — | — |
NCT00895934CT.gov Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML | — | Completed | — | — | — |
NCT00882102CT.gov Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS) | — | Completed | — | — | — |
NCT00798213CT.gov SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED) | — | Terminated | — | — | — |
NCT00658814CT.gov Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT00660036CT.gov Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT00909168CT.gov Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT00968071CT.gov Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT00860639CT.gov Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk | — | Completed | — | — | — |
NCT00766116CT.gov Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT00460447CT.gov Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation | — | Unknown | — | — | — |
NCT00143975CT.gov Gemtuzumab Ozogamicin in Combination With A-HAM in Refractory AML (GO-A-HAM) | — | Completed | — | — | — |
NCT00669890CT.gov Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML | — | Terminated | — | — | — |
NCT00476541CT.gov NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01020539CT.gov Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia | — | Completed | — | — | — |
NCT00962767CT.gov Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission | — | Completed | — | — | — |
NCT00037596CT.gov Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00044733CT.gov Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant | — | Completed | — | — | — |
NCT01039363CT.gov Vorinostat Combined With Gemtuzumab Ozogamicin, Idarubicin and Cytarabine in Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT01869803CT.gov Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia | — | Approved For Marketing | — | — | — |
NCT02312037CT.gov Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy | — | No Longer Available | — | — | — |
NCT00037583CT.gov Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia | — | 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 |
|---|---|---|---|
| Gemtuzumab Ozogamicin (this asset) | German Cancer Research Center | P3 | 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 Gemtuzumab Ozogamicin
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Leukemia | — | P3 | BB · 69 |
| Myelodysplastic Syndrome | — | P3 | BB · 67 |
| Acute Monocytic Leukemia | — | P2 | BB · 64 |
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. Gemtuzumab Ozogamicin 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/gemtuzumab-ozogamicin-acute-myeloid-leukemia
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