Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

November 7, 2024 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML

MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Setting up a multicenter, MRD (Minimal Residual Disease)-driven study that relies on addition of gemtuzumab ozogamicin to conventional chemotherapy to reduce the pre-transplant levels of MRD of patients with favorable/intermediate-risk (according to ELN 2017) AML. Post-consolidation assessment of MRD will be exploited to establish the final risk assignment and to verify whether the delivery of a post remission therapy intensity (AuSCT, Autologous Stem Cell Transplant, vs ASCT, Allogeneic Stem Cell Transplant) of which is MRD-driven will improve the outcome in terms of anti-leukemic efficacy.

Study Type

Interventional

Enrollment (Estimated)

414

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • Recruiting
        • A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia
        • Contact:
          • Zallio
      • Ancona, Italy
        • Recruiting
        • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
        • Contact:
      • Ascoli Piceno, Italy
        • Recruiting
        • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
        • Contact:
      • Avellino, Italy
        • Recruiting
        • AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto
        • Contact:
          • Storti
      • Bari, Italy
        • Recruiting
        • AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto
        • Contact:
          • Carluccio
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola - Malpighi - UOC Ematologia
        • Contact:
          • Curti
      • Caserta, Italy
        • Recruiting
        • Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia
        • Contact:
      • Castelfranco Veneto, Italy
        • Recruiting
        • U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
        • Contact:
      • Civitanova Marche, Italy
        • Recruiting
        • Asur Marche Area Vasta 3 - Presidio Ospedaliero Civitanova Marche - Uods Ematologia
        • Contact:
      • Cona, Italy
        • Recruiting
        • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
        • Contact:
      • Cremona, Italy
        • Recruiting
        • Asst Di Cremona - Ospedale Di Cremona - Uo Ematologia
        • Contact:
      • Firenze, Italy
      • Frosinone, Italy
      • Genova, Italy
      • Latina, Italy
        • Recruiting
        • Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC Ematologia
        • Contact:
          • Cimino
      • Lecce, Italy
        • Recruiting
        • ASL Le/1 P.O. Vito Fazzi - UO Ematologia
        • Contact:
          • Di Renzo
      • Mestre, Italy
      • Milano, Italy
      • Milano, Italy
      • Milano, Italy
        • Recruiting
        • ISTITUTO EUROPEO DI ONCOLOGIA IRCCS - MILANO - DIVISIONE DI ONCOEMATOLOGIA 176 Milano Divisione di Onco-Ematologia Istituto Europeo
        • Contact:
      • Modena, Italy
      • Napoli, Italy
        • Recruiting
        • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
        • Contact:
      • Napoli, Italy
      • Orbassano, Italy
        • Recruiting
        • Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
        • Contact:
      • Pagani, Italy
        • Recruiting
        • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
        • Contact:
      • Palermo, Italy
        • Recruiting
        • Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
        • Contact:
      • Palermo, Italy
        • Recruiting
        • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
        • Contact:
      • Pavia, Italy
        • Recruiting
        • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
        • Contact:
      • Perugia, Italy
        • Recruiting
        • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
        • Contact:
      • Pesaro, Italy
      • Pescara, Italy
        • Recruiting
        • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
        • Contact:
      • Piacenza, Italy
        • Recruiting
        • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
        • Contact:
      • Ravenna, Italy
        • Recruiting
        • Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
        • Contact:
      • Reggio Emilia, Italy
        • Recruiting
        • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
        • Contact:
      • Rimini, Italy
        • Recruiting
        • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
        • Contact:
      • Roma, Italy
        • Recruiting
        • Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
        • Contact:
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
        • Contact:
      • Roma, Italy
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
        • Contact:
      • Sassari, Italy
        • Recruiting
        • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
        • Contact:
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
        • Contact:
      • Treviso, Italy
        • Recruiting
        • Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
        • Contact:
      • Trieste, Italy
      • Udine, Italy
        • Recruiting
        • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed written informed consent according to ICH/EU/GCP and national/local laws
  2. Patients aged between 18 and 60 years
  3. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
  4. Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of ≥ 6 months duration)
  5. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML)
  6. WHO performance status 0-3
  7. Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serum bilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered due to organ leukemic involvement
  8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram
  9. Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
  10. Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.

Exclusion Criteria:

  1. Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
  2. Acute promyelocytic leukemia
  3. Blast crisis of chronic myeloid leukemia
  4. FLT3-ITD/TKD positive AML
  5. AML supervening after other myeloproliferative disease
  6. AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration
  7. Therapy-related AML
  8. Other active or progressive malignant diseases.
  9. Inadequate renal or liver function (metabolic abnormalities > 2-2.5 times the normal upper limit)
  10. Severe heart failure requiring diuretics
  11. Ejection fraction < 50%
  12. Uncontrolled infections
  13. Severe concomitant neurological or psychiatric diseases
  14. Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of chemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm

Induction:

Gemtuzumab 3 mg/m2 day 1,4,7 Daunorubicin 60 mg/m2 day 1-3 Cytosine arabinoside 200 mg/m2 day 1-7

Consolidation:

Gemtuzumab 3 mg/m2 day 1 Daunorubicin 50 mg/m2 day 4-6 Cytosine arabinoside 500 mg/m2 twice a day, day 1-6

Allogeneic transplantation or Autologous transplantation according to MRD level

clinical observation
Drug: Gemtuzumab Ozogamicin
Patients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity of GO in combination with chemotherapy in terms of MRD negativity achievement
Time Frame: 2 months
Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML1819

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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