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NCT00049179COMPLETEDanonymous

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Sponsor

Source record

SWOG Cancer Research Network

Phase

Source record

Phase 2

Modality

AI-normalized

small molecule

Target

AI-normalized

CD33 positive acute myeloid leukemia (AML) cells, utilizing gemtuzumab ozogamicin as a monoclonal antibody conjugate to deliver cytotoxic agents.

Indication / condition

AI-normalized

Leukemia

Intervention

Source record

cytarabine, gemtuzumab ozogamicin

Related intelligence directories

Indication directory: LeukemiaModality directory: small moleculeTarget directory: CD33 positive acute myeloid leukemia (AML) cells

Source & freshness

Source record

NCT ID

NCT00049179

Original source

ClinicalTrials.gov

Source last updated

Mar 06, 2015

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT00049179

Title

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Sponsor

SWOG Cancer Research Network

Status

COMPLETED

Phase

Phase 2

Condition raw

Leukemia

Condition normalized

Leukemia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

CD33 positive acute myeloid leukemia (AML) cells, utilizing gemtuzumab ozogamicin as a monoclonal antibody conjugate to deliver cytotoxic agents.

Target normalized

CD33 positive acute myeloid leukemia (AML) cells, utilizing gemtuzumab ozogamicin as a monoclonal antibody conjugate to deliver cytotoxic agents.

Interventions

cytarabine, gemtuzumab ozogamicin

Public preview

Source record

The Phase II study of gemtuzumab ozogamicin combined with standard dose cytarabine targets relapsed acute myeloid leukemia (AML) patients, a significant market with unmet medical needs. The combination therapy aims to enhance efficacy over standard treatments, potentially positioning the asset favorably against competitors in the AML space. Given the historical challenges in treating relapsed AML, successful outcomes could lead to expanded use and market share, particularly in CD33-positive patient populations. The collaboration with SWOG and the National Cancer Institute (NCI) enhances credibility and may facilitate further clinical development and regulatory pathways.

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 Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

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

Generated

Jun 19, 2026

NCT ID

NCT00049179

Status

COMPLETED

Phase

Phase 2

Sponsor

SWOG Cancer Research Network

Executive brief

Investment-Ready Snapshot

The Phase II study of gemtuzumab ozogamicin combined with standard dose cytarabine targets relapsed acute myeloid leukemia (AML) patients, a significant market with unmet medical needs. The combination therapy aims to enhance efficacy over standard treatments, potentially positioning the asset favorably against competitors in the AML space. Given the historical challenges in treating relapsed AML, successful outcomes could lead to expanded use and market share, particularly in CD33-positive patient populations. The collaboration with SWOG and the National Cancer Institute (NCI) enhances credibility and may facilitate further clinical development and regulatory pathways.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMar 06, 2015
Internal syncJun 19, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT00049179

Indication

Leukemia

Modality

small molecule

Target

CD33 positive acute myeloid leukemia (AML) cells, utilizing gemtuzumab ozogamicin as a monoclonal antibody conjugate to deliver cytotoxic agents.

Intervention

cytarabine, gemtuzumab ozogamicin

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.