NCT02473146 (ALFA1401) is a Phase 2, PHASE3 clinical trial of Gemtuzumab ozogamicin (GO) in Acute Myeloid Leukemia, sponsored by Versailles Hospital.

Who is sponsoring NCT02473146?

NCT02473146 is sponsored by Versailles Hospital.

What drugs are being tested in NCT02473146?

Interventions in NCT02473146: Gemtuzumab ozogamicin (GO).

What condition does NCT02473146 study?

NCT02473146 studies Acute Myeloid Leukemia.

Is NCT02473146 still recruiting?

NCT02473146 is currently completed. Last updated 2 February 2024.

Last reviewed 2024-02-02 · How we verify

NCT02473146: ALFA1401

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4

Completed Phase 2, PHASE3 Last updated 2 February 2024

What this trial tests

Phase 2, PHASE3 trial testing Gemtuzumab ozogamicin (GO) in Acute Myeloid Leukemia in 225 participants. Completed in 7 September 2023.

Timeline

18 November 2015

Primary endpoint
26 February 2021

7 September 2023

Quick facts

Lead sponsor	Versailles Hospital
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	225
Start date	18 November 2015
Primary completion	26 February 2021
Estimated completion	7 September 2023
Sites	21 locations across France

Drugs / interventions tested

Gemtuzumab ozogamicin (GO) — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Versailles Hospital

Who can join

Adults 60 to 80, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged \>60 years. Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Novel therapy in Acute myeloid leukemia (AML): moving toward targeted approaches.
Winer ES, Stone RM. · · 2019 · cited 92× · PMID 31321011 · DOI 10.1177/2040620719860645
Natural killer cell-based immunotherapy for acute myeloid leukemia.
Xu J, Niu T. · · 2020 · cited 83× · PMID 33287858 · DOI 10.1186/s13045-020-00996-x
Prognostic impact of DDX41 germline mutations in intensively treated acute myeloid leukemia patients: an ALFA-FILO study.
Duployez N, Largeaud L, Duchmann M, Kim R, et al · · 2022 · cited 69× · PMID 35443031 · DOI 10.1182/blood.2021015328
Novel CAR T therapy is a ray of hope in the treatment of seriously ill AML patients.
Marofi F, Rahman HS, Al-Obaidi ZMJ, Jalil AT, et al · · 2021 · cited 64× · PMID 34412685 · DOI 10.1186/s13287-021-02420-8
Gemtuzumab ozogamicin and novel antibody-drug conjugates in clinical trials for acute myeloid leukemia.
Yu B, Liu D. · · 2019 · cited 37× · PMID 31695916 · DOI 10.1186/s40364-019-0175-x
Glycosylation Targeting: A Paradigm Shift in Cancer Immunotherapy.
Ren X, Lin S, Guan F, Kang H. · · 2024 · cited 30× · PMID 38725856 · DOI 10.7150/ijbs.93806
Therapeutic Antibodies for Myeloid Neoplasms-Current Developments and Future Directions.
Schürch CM. · · 2018 · cited 30× · PMID 29868474 · DOI 10.3389/fonc.2018.00152
Update on acute myeloid leukemia stem cells: New discoveries and therapeutic opportunities.
Stahl M, Kim TK, Zeidan AM. · · 2016 · cited 15× · PMID 27822339 · DOI 10.4252/wjsc.v8.i10.316

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

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Other Versailles Hospital trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02473146 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Versailles Hospital
Last refreshed: 2 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02473146.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing