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NCT03531918COMPLETEDanonymous

A Single-Center Phase 1/2 Study of Single- or Fractioned-Dose Gemtuzumab Ozogamicin in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone for Previously Untreated Adult Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm

Sponsor

Source record

Fred Hutchinson Cancer Center

Phase

Source record

Phase 1/2

Modality

AI-normalized

small molecule

Target

AI-normalized

CD33 (targeted by gemtuzumab ozogamicin, an antibody-drug conjugate delivering calicheamicin to CD33-expressing cells)

Indication / condition

AI-normalized

Acute Myeloid Leukemia

Intervention

Source record

Cladribine, Cytarabine, Gemtuzumab Ozogamicin, Recombinant Granulocyte Colony-Stimulating Factor, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride

Source & freshness

Source record

NCT ID

NCT03531918

Original source

ClinicalTrials.gov

Source last updated

Aug 30, 2023

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT03531918

Title

A Single-Center Phase 1/2 Study of Single- or Fractioned-Dose Gemtuzumab Ozogamicin in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone for Previously Untreated Adult Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm

Sponsor

Fred Hutchinson Cancer Center

Status

COMPLETED

Phase

Phase 1/2

Condition raw

Acute Myeloid Leukemia

Condition normalized

Acute Myeloid Leukemia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

CD33 (targeted by gemtuzumab ozogamicin, an antibody-drug conjugate delivering calicheamicin to CD33-expressing cells)

Target normalized

CD33 (targeted by gemtuzumab ozogamicin, an antibody-drug conjugate delivering calicheamicin to CD33-expressing cells)

Interventions

Cladribine, Cytarabine, Gemtuzumab Ozogamicin, Recombinant Granulocyte Colony-Stimulating Factor, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride

Public preview

Source record

The trial, sponsored by Fred Hutchinson Cancer Center in collaboration with Pfizer, investigates the combination of gemtuzumab ozogamicin with G-CSF, cladribine, cytarabine, and mitoxantrone for treating previously untreated adult acute myeloid leukemia (AML) or high-grade myeloid neoplasms. Given the high unmet need in AML treatment, successful outcomes could position this regimen favorably in a competitive landscape dominated by existing therapies such as standard chemotherapy and newer agents like FLT3 inhibitors. The trial's completion and subsequent results will be critical for assessing the commercial viability and potential market entry strategies for this combination therapy.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Single-Center Phase 1/2 Study of Single- or Fractioned-Dose Gemtuzumab Ozogamicin in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone for Previously Untreated Adult Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 16, 2026

NCT ID

NCT03531918

Status

COMPLETED

Phase

Phase 1/2

Sponsor

Fred Hutchinson Cancer Center

Executive brief

Investment-Ready Snapshot

The trial, sponsored by Fred Hutchinson Cancer Center in collaboration with Pfizer, investigates the combination of gemtuzumab ozogamicin with G-CSF, cladribine, cytarabine, and mitoxantrone for treating previously untreated adult acute myeloid leukemia (AML) or high-grade myeloid neoplasms. Given the high unmet need in AML treatment, successful outcomes could position this regimen favorably in a competitive landscape dominated by existing therapies such as standard chemotherapy and newer agents like FLT3 inhibitors. The trial's completion and subsequent results will be critical for assessing the commercial viability and potential market entry strategies for this combination therapy.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedAug 30, 2023
Internal syncJun 13, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03531918

Indication

Acute Myeloid Leukemia

Modality

small molecule

Target

CD33 (targeted by gemtuzumab ozogamicin, an antibody-drug conjugate delivering calicheamicin to CD33-expressing cells)

Intervention

Cladribine, Cytarabine, Gemtuzumab Ozogamicin, Recombinant Granulocyte Colony-Stimulating Factor, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.