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NCT00049517COMPLETEDanonymous

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Sponsor

Source record

Eastern Cooperative Oncology Group

Phase

Source record

Phase 3

Modality

AI-normalized

protein therapy

Target

AI-normalized

Combination chemotherapy with daunorubicin and cytarabine, with potential addition of gemtuzumab ozogamicin targeting CD33 in acute myeloid leukemia (AML).

Indication / condition

AI-normalized

Leukemia

Intervention

Source record

sargramostim, busulfan, cyclophosphamide, cytarabine, gemtuzumab ozogamicin (GO), Daunorubicin, Autologous HCT, Allogeneic HCT

Source & freshness

Source record

NCT ID

NCT00049517

Original source

ClinicalTrials.gov

Source last updated

Jun 15, 2023

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT00049517

Title

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Sponsor

Eastern Cooperative Oncology Group

Status

COMPLETED

Phase

Phase 3

Condition raw

Leukemia

Condition normalized

Leukemia

Modality raw

protein therapy

Modality normalized

protein therapy

Target raw

Combination chemotherapy with daunorubicin and cytarabine, with potential addition of gemtuzumab ozogamicin targeting CD33 in acute myeloid leukemia (AML).

Target normalized

Combination chemotherapy with daunorubicin and cytarabine, with potential addition of gemtuzumab ozogamicin targeting CD33 in acute myeloid leukemia (AML).

Interventions

sargramostim, busulfan, cyclophosphamide, cytarabine, gemtuzumab ozogamicin (GO), Daunorubicin, Autologous HCT, Allogeneic HCT

Public preview

Source record

This Phase 3 trial sponsored by the Eastern Cooperative Oncology Group investigates the efficacy of a combination chemotherapy regimen followed by autologous stem cell transplantation in adult patients with acute myeloid leukemia (AML). The trial's outcomes could significantly impact treatment protocols for AML, a market projected to grow due to increasing incidence rates and advancements in therapeutic options. The inclusion of gemtuzumab ozogamicin, a monoclonal antibody, may provide a competitive edge if proven effective, particularly against standard chemotherapy regimens. Companies involved in AML therapies should monitor the results closely for potential shifts in treatment paradigms and market opportunities.

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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