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A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

AGORA-1 /ALFA 2100 Study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

NCT05199051•Centre Antoine Lacassagne

View on ClinicalTrials.gov

Summary

This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose of cytarabine and a divided dose of GO in adult patients with R / R AML with an FLT3-ITD and/or FLT3-TKD mutation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients aged 18 years old or more
•Confirmed diagnosis of R/R AML positive for CD33 antigen as determined locally by immunophenotyping according to routine practice, defined as:
•* AML refractory to 1 or 2 intensive chemotherapy courses or a treatment by hypomethylating agents (HMAs)
•* Or AML in first hematologic relapse or progression after front-line therapy, including intensive chemotherapy or hypomethylating agents (HMAs).
•* Previous treatments with FLT3 inhibitors (other than gilteritinib) are allowed
•* R/R AML secondary to a prior chemotherapy or radiotherapy for another cancer (tAML) could be included.
•Presence of a FLT3-ITD mutation (allelic ratio ≥0.05 at last evaluation)\* or a FLT3 TKD mutation
•Patient with no contraindication to gemtuzumab ozogamicin (GO), cytarabine and gilteritinib
•ECOG performance status ≤2
•AST and ALT ≤ 2.5 x upper the limit of normal (ULN) and/or total and direct serum bilirubin ≤ 1.5 x ULN unless considered due to leukemia
+3 more criteria

Exclusion Criteria

•Acute promyelocytic leukemia or AML with BCR-ABL1 gene fusion
•Secondary AML (sAML) defined by a history of prior myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPN) including chronic myelomonocytic leukemia (CMML)
•Patient with contraindications to the administration of gemtuzumab ozogamicin (GO), cytarabine and gilteritinib. Refer to the SPCs of the molecules mentioned concerning the contraindications, special warnings, precautions for use, dose modifications in the event of toxicity, contraception and monitoring of patients and drugs prohibited or to be used with caution.
•Proven central nervous system leukemic involvement
•Prior allogeneic HSCT within the last 6 months and/or history of acute GVHD of grade \>1
•Prior treatment with gemtuzumab ozogamicin within the last 3 months preceding the initiation of the treatment in the present clinical trial
•Uncontrolled or active malignant disease within prior 12 months (excluding cutaneous basal cell carcinoma, "in-situ" carcinoma of the cervix or breast, or other local malignancy excised)
•Uncontrolled or significant cardiovascular history or symptoms including:
•* Prior anthracycline exposure equivalent to more than 550 mg/m2 of daunorubicin
•* History of clinically relevant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation or torsade de pointes)
+25 more criteria

Locations (12)

CHU d'Amiens

Amiens, France

CHU d'Angers

Angers, France

CHU Bordeaux

Bordeaux, France

CHU de Caen

Caen, France

CHMS de Chambery

Chambéry, France

HIA Percy

Clamart, France

CHU Limoges

Limoges, France

CHRU Nancy

Nancy, France

Centre Hospitalier Universitaire de Nice

Nice, France

Hôpital Saint Louis

Paris, France

Key Dates

Start Date

June 3, 2023

Primary Completion Date

July 10, 2028

Completion Date

July 10, 2028

Last Updated

January 5, 2026

Enrollment

ACTUAL participants

Conditions

AMLLeukaemia (Acute Myeloid)

Interventions

Gemtuzumab ozogamicine - Cytarabine - Gilteritinib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

Inclusion Criteria

Exclusion Criteria

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A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

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