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LeukemiaPhase 3AML-17NCT00052299

Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia

A Phase 3 study testing cytarabine, etoposide and gemtuzumab ozogamicin in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 55 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 61 to 75 years
Conditions the study is for
Leukemia
What is being tested?
cytarabine, etoposide and gemtuzumab ozogamicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
472 participants
Where
55 sitesin 7 countries
Study dates
Sep 2002to Feb 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML)
  • Bone marrow blasts at least 20% by bone marrow aspiration or biopsy
  • FAB subtypes M0-M2 and M4-M7
  • No acute promyelocytic leukemia (FAB subtype M3)
  • Previously untreated primary or secondary AML, including AML after myelodysplastic syndromes
  • Hydroxyurea and/or corticosteroid therapy for no more than 14 days allowed
  • No blast crisis of chronic myelogenous leukemia
  • No AML supervening after other myeloproliferative diseases
  • No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

  • 61 to 75

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC less than 30,000/mm^3 (pretreatment with hydroxyurea for no more than 14 days allowed)

Hepatic

  • Bilirubin no greater than 3 times upper limit of normal (ULN)

Renal

  • Creatinine no greater than 3 times ULN

Cardiovascular

  • No concurrent severe cardiovascular disease
  • No arrhythmias requiring chronic treatment
  • No congestive heart failure
  • No symptomatic ischemic heart disease

Pulmonary

  • No severe pulmonary dysfunction (CTC grade 3-4)

Other

  • HIV negative
  • No other uncontrolled infection
  • No other concurrent malignant disease
  • No severe concurrent neurological or psychiatric disease
  • No prior alcohol abuse
  • No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent hematopoietic growth factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) except for life-threatening infection due to neutropenia

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior enrollment in this trial

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

Italy33 sites

  • Universita Degli Studi di Bari

    Bari, 70124

  • Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138

  • Azienda Sanitaria di Bolzano

    Bolzano, 39100

  • Ospedale Binaghi

    Cagliari, 090100

  • Ospedale Oncologico A. Businco

    Cagliari, 09121

  • Ospedale Ferrarotto

    Catania, 95124

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

  • Azienda Istituti Ospitalieri

    Cremona, 26100

  • Universita di Ferrara

    Ferrara, 44100

  • Ospedale S. Antonio Abate

    Gallarate Varese, 21013

  • Ospedale San Martino

    Genoa, 16132

  • Universita degli Studi di Messina

    Messina, 98122

  • Azienda Ospedaliera Papardo

    Messina

  • Ospedale Civile Umberto I

    Mestre, 30174

  • Azienda Ospedaliera - Universitaria di Modena

    Modena, 41100

  • Azienda Ospedaliera "A. Cardarelli"

    Naples, 80127

  • Federico II University Medical School

    Naples, 80131

  • Azienda Ospedaliera Maggiore Della Carita

    Novara, 28100

  • Azienda Ospedale S. Luigi at University of Torino

    Orbassano, 10043

  • Azienda Ospedaliera Policlinico Paolo Giaccone

    Palermo, 90127

  • Ospedale Cervello

    Palermo, 90146

  • Ospedale La Maddalena - Palermo

    Palermo

  • Perugia Regional Cancer Center

    Perugia, 06122

  • Azienda Ospedale - d "S. Salvatore"

    Pesaro, I-61100

  • Ospedale Civile Pescara

    Pescara, 65100

  • Ospedale Sant' Eugenio

    Rome, 00144

  • Libero Istituto Universitario Campus Bio-Medico

    Rome, 00155

  • Universita Degli Studi "La Sapeinza"

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • H. San Giovanni-Addolorata Hospital

    Rome, 00184

  • Istituto di Ematologia Universita - University di Sassari

    Sassari, 07100

  • Policlinico G. B. Rossi - Borgo Roma

    Verona, 37134

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

Belgium8 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Centre Hospitalier Universitaire Brugmann

    Brussels, B 1020

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

  • Centre Hospitalier Peltzer-La Tourelle

    Verviers, B-4800

Other trials in Belgium

Netherlands5 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5211 NL

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, 6500 HB

  • Maxima Medisch Centrum - Veldhoven

    Veldhoven, 5500 MB

Other trials in Netherlands

France3 sites

  • Hopital Edouard Herriot

    Lyon, 69437

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hotel Dieu de Paris

    Paris, 75181

Other trials in France

Germany3 sites

  • Klinikum der Albert - Ludwigs - Universitaet Freiburg

    Freiburg im Breisgau, D-79106

  • Ruprecht - Karls - Universitaet Heidelberg

    Heidelberg, D-69117

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

Other trials in Germany

Austria2 sites

  • A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung

    Linz, 4010

  • Allgemeines Krankenhaus - Universitatskliniken

    Vienna, A-1090

Other trials in Austria

Portugal1 site

  • Hospital Escolar San Joao

    Porto, 4200

Other trials in Portugal

About this study

Official title: Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC-LG and the GIMEMA-ALWP

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the antileukemic activity of standard induction chemotherapy with or without gemtuzumab ozogamicin in elderly patients with previously untreated acute myeloid leukemia.
  • Determine the overall survival of patients treated with these regimens.
  • Determine the rate of response, disease-free survival, event-free survival, incidence of relapse, and incidence of death of patients treated with these regimens.
  • Determine the rate, type, and grade of toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (61-69 vs 70-75), CD33 positivity (less than 5% vs 5-19% vs 20-80% vs more than 80% vs unknown), initial WBC before hydroxyurea administration if needed (less than 30,000/mm^3 vs at least 30,000/mm^3), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I:
  • Induction (phase I): Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15.
  • Induction (phase II/MICE regimen): Beginning between days 50 and 53, patients receive mitoxantrone IV over 30 minutes on days 1, 3, and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-7. Bone marrow evaluation is performed on day 29. Patients with partial remission (PR) receive a second course of MICE chemotherapy regimen. Patients with complete remission (CR) after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients with progressive disease go off therapy.
  • Consolidation: Beginning within 4 weeks of documentation of CR, patients receive gemtuzumab ozogamicin IV over 2 hours on day 0; idarubicin IV on days 1, 3, and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-5. After at least day 30, patients receive a second consolidation course in the absence of disease progression or unacceptable toxicity.
  • Arm II:
  • Induction (MICE regimen): Patients receive mitoxantrone, etoposide, and cytarabine as in arm I induction. Bone marrow evaluation is performed on day 29. Patients with PR receive a second course of MICE chemotherapy regimen. Patients with CR after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients with progressive disease go off therapy.
  • Consolidation: Patients receive idarubicin, etoposide, and cytarabine as in arm I consolidation.

Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 450 patients (225 per treatment arm) will be accrued for this study within 3.75 years.

Conditions
Leukemia
Being tested
cytarabine, etoposide, gemtuzumab ozogamicin, idarubicin, mitoxantrone hydrochloride
Keywords
adult acute monocytic leukemia (M5b), adult acute erythroid leukemia (M6), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), untreated adult acute myeloid leukemia, secondary acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
Medical subject headings
Leukemia, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00052299
Study groupRoleWhat they receive
ARM AExperimentalGO + MICE for remission induction followed by GO + mini-ICE for consolidation
Receives: Drug: cytarabine; Drug: etoposide; Drug: gemtuzumab ozogamicin; Drug: idarubicin; Drug: mitoxantrone hydrochloride
ARM BActive comparatorMICE for remission induction followed by mini-ICE for consolidation
Receives: Drug: cytarabine; Drug: etoposide; Drug: idarubicin; Drug: mitoxantrone hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (6)

  1. Response (complete remission [CR] or complete remission with incomplete recovery of platelet count [CRp]) rate after induction

  2. Disease-free survival after CR/CRp

  3. Incidence of relapse after CR/CRp

  4. Incidence of death without relapse after CR/CRp

  5. Event-free survival

  6. Toxicity (highest grade) assessed by International Working Group CTC v2.0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2002
  3. Primary completionJan 2008
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
472 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052299
Sponsor's protocol ID
EORTC-06012
Other IDs
EORTC-06012, AML-17, GIMEMA-AML-17
Acronym
AML-17
Status last verified
Aug 2012
First submitted
24 Jan 2003
Last updated
27 Aug 2012
Results posted
No

Publications

  • Amadori S, Suciu S, Stasi R, Salih HR, Selleslag D, Muus P, De Fabritiis P, Venditti A, Ho AD, Lubbert M, Thomas X, Latagliata R, Halkes CJ, Falzetti F, Magro D, Guimaraes JE, Berneman Z, Specchia G, Karrasch M, Fazi P, Vignetti M, Willemze R, de Witte T, Marie JP. Sequential combination of gemtuzumab ozogamicin and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia: results of a randomized phase III trial by the EORTC and GIMEMA consortium (AML-17). J Clin Oncol. 2013 Dec 10;31(35):4424-30. doi: 10.1200/JCO.2013.49.0771. Epub 2013 Oct 14.

    PubMed 24127442

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cytarabine, etoposide and gemtuzumab ozogamicin in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 55 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Italy, Belgium, Netherlands, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00052299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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