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LeukemiaPhase 2/3AML-19NCT00091234

Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

A Phase 2/3 study testing gemtuzumab ozogamicin in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 45 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin 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 years and older
Conditions the study is for
Leukemia
What is being tested?
gemtuzumab ozogamicin
How many people
279 participants
Where
45 sitesin 3 countries
Study dates
Jun 2004to Dec 2013
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute myeloid leukemia (AML)
  • At least 20% bone marrow blasts by bone marrow aspiration or biopsy
  • All subtypes except M3 (acute promyelocytic leukemia) are allowed
  • Previously untreated primary or secondary disease (including AML after myelodysplastic syndromes)
  • Ineligible for intensive chemotherapy, as defined by 1 of the following criteria:
  • 61 to 75 years old AND WHO performance status > 2 AND/OR unwilling to receive intensive chemotherapy
  • Over 75 years old
  • No blast crisis of chronic myeloid leukemia
  • No AML supervention after other myeloproliferative disease
  • WBC < 30,000/mm^3 and meets 1 of the following criteria:
  • WBC < 30,000/mm^3 at diagnosis AND had no prior treatment with hydroxyurea
  • WBC ≥ 30,000/mm^3 at diagnosis AND received mandatory pretreatment with hydroxyurea (up to 14 days duration) until WBC < 30,000/mm^3
  • No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

  • See Disease Characteristics
  • 61 and over

Performance status

  • See Disease Characteristics

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No arrhythmia requiring chronic treatment
  • No congestive heart failure
  • No symptomatic ischemic heart disease
  • No other severe cardiovascular disease

Pulmonary

  • No severe pulmonary dysfunction ≥ grade 3

Other

  • No alcohol abuse
  • No severe neurological or psychiatric disease
  • No active uncontrolled infection or severe systemic infection
  • No other malignancy
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent antiangiogenic drugs

Chemotherapy

  • See Disease Characteristics
  • Concurrent low-dose cytostatic agents (i.e., thioguanine or mercaptopurine) allowed for palliative care (standard supportive care arm only)

Endocrine therapy

  • Prior corticosteroids (duration ≤ 14 days ) for primary or secondary AML allowed

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent cytotoxic drugs
  • No other concurrent experimental therapy
  • No concurrent tyrosine kinase inhibitors

Trial locations and contacts

45 sites in 3 countries.

Hilde Breyssens contact

hilde.breyssens@eortc.be

45 sites in 3 countries

Italy34 sites, 34 recruiting

  • Ospedale S Donato, USL-8

    Arezzo Cap

    Recruiting

  • Universita Degli Studi di Bari

    Bari, 70124

    Contact Person, 39-080-547-8660

    Recruiting

  • Universita Di Brescia

    Brescia

    Recruiting

  • Ospedale Binaghi

    Cagliari, 090100

    Contact Person, 39-070-609-3149

    Recruiting

  • Ospedale Oncologico A. Businco

    Cagliari, 09121

    Contact Person, 39-070-609-5204

    Recruiting

  • Ospedale Regionale A Pugliese

    Cantanzaro

    Recruiting

  • Ospedale Ferrarotto

    Catania, 95124

    Contact Person, 39-095-743-5915

    Recruiting

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

    Contact Person, 39-961-883-346

    Recruiting

  • Universita di Ferrara

    Ferrara, 44100

    Contact Person, 39-532-209-100

    Recruiting

  • Azienda Ospedaliera Vito Fazzi

    Lecce, 73100

    Contact Person, 39-083-266-1235

    Recruiting

  • Azienda Ospedaliera - Universitaria di Modena

    Modena, 41100

    Contact Person, 39-059-422-4373

    Recruiting

  • Ospedale Di Montefiascone

    Montefiascone, I-01027

    Contact Person, 39-07-618-331

    Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

    Naples, 80127

    Contact Person, 39-081-747-3011

    Recruiting

  • Ospedale Maggiore della Carita

    Novara

    Recruiting

  • Azienda Ospedaliera Policlinico Paolo Giaccone

    Palermo, 90127

    Contact Person, 39-091-655-2321

    Recruiting

  • Ospedale La Maddalena - Palermo

    Palermo

    Contact Person, 39-91-680-6111

    Recruiting

  • Azienda Ospedaliera Di Parma

    Parma, 43100

    Contact Person, 39-0521-702-441

    Recruiting

  • Policlinico Monteluce

    Perugia, 06122

    Massimo F. Martelli, MD, 39-75-5783219, ematol@unipg.it

    Recruiting

  • Ospedale San Salvatore

    Pesaro, I-61100

    G. Lucarelli, 0039-0721-36424

    Recruiting

  • Ospedale Civile Pescara

    Pescara, 65100

    Contact Person

    Recruiting

  • Ospedale San Carlo

    Potenza

    Recruiting

  • Ospedale Sta. Maria Delle Croci

    Ravenna, 48100

    Contact Person, 39-544-285-247

    Recruiting

  • Ospedale Sant'Andrea

    Roma

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, 00133

    Contact Person, 39-06-20-901

    Recruiting

  • Ospedale Sant' Eugenio

    Rome, 00144

    Contact Person, 39-06-5100-2569

    Recruiting

  • Libero Istituto Universitario Campus Bio-Medico

    Rome, 00155

    Contact, 39-06-2254-1366

    Recruiting

  • Azienda Policlinico Umberto Primo

    Rome, 00161

    Franco Mandelli, 39-06-85-79-51

    Recruiting

  • Istituto Regina Elena

    Rome, 00161

    Contact Person, 39-06-4985-2201

    Recruiting

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

    Contact Person, 39-06-3015-5556

    Recruiting

  • H. San Giovanni-Addolorata Hospital

    Rome, 00184

    Contact Person

    Recruiting

  • Universita Degli Studi "La Sapeinza"

    Rome

    Giuliana Alimena, 39-06-857-951

    Recruiting

  • Istituto di Ematologia Universita - University di Sassari

    Sassari, 07100

    Contact Person, 39-79-228-280

    Recruiting

  • Universita di Siena

    Siena, 53100

    Contact Person, 39-0577-586-429

    Recruiting

  • Ospedale Maggiore dell' Universita

    Trieste, 34100

    Contact Person, 39-040-399-2232

    Recruiting

Other trials in Italy

Belgium7 sites, 7 recruiting

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, 2020

    Contact Person, 32-3-280-3111

    Recruiting

  • AZ Sint-Jan

    Bruges, 8000

    Contact Person, 32-50-45-2111

    Recruiting

  • Institut Jules Bordet

    Brussels, 1000

    Contact Person, 32-2-541-3510

    Recruiting

  • Hopital Universitaire Erasme

    Brussels, 1070

    Contact Person, 32-2-555-3806

    Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

    Contact Person, 32-03-821-3375

    Recruiting

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

    Contact Person, 32-4-366-7111

    Recruiting

  • Centre Hospitalier Peltzer-La Tourelle

    Verviers, B-4800

    Contact Person, 328-721-2111

    Recruiting

Other trials in Belgium

Netherlands4 sites, 4 recruiting

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5211 NL

    Contact Person, 31-73-699-2000

    Recruiting

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

    Contact Person, 31-20-599-9111

    Recruiting

  • Leiden University Medical Center

    Leiden, 2300 RC

    Contact Person, 31-71-526-9111

    Recruiting

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

    Contact Person

    Recruiting

Other trials in Netherlands

About this study

Official title: Gemtuzumab Ozogamicin (GO) Monotherapy Versus Standard Supportive Care for Previously Untreated AML in Elderly Patients Who Are Not Eligible for Intensive Chemotherapy: A Randomized Phase II/III Trial (AML-19) of the EORTC-LG and GIMEMA-ALWP

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether gemtuzumab ozogamicin is more effective than standard supportive care in treating older patients who have acute myeloid leukemia.

PURPOSE: This randomized phase II/III trial is studying two different gemtuzumab ozogamicin regimens to see how well they work compared to standard supportive care in treating older patients with previously untreated acute myeloid leukemia.

Read the detailed description

OBJECTIVES:

  • Compare the feasibility, toxicity, and antileukemic activity of two different dosing regimens of gemtuzumab ozogamicin (GO) vs standard supportive care in older patients with previously untreated acute myeloid leukemia who are not candidates for intensive chemotherapy. (phase II)
  • Compare the efficacy and toxicity of the best dosing regimen of GO selected from phase II vs standard supportive care, in terms of overall survival, in these patients. (phase III)

OUTLINE: This is a randomized, open-label, multicenter phase II study followed by a phase III study. Patients are stratified according to age (61 to 75 vs 76 to 80 vs 81 and over), CD33-positivity of bone marrow blasts (< 20% vs 20-80% vs > 80% vs unknown), initial WBC before hydroxyurea administration (< 30,000/mm^3 vs ≥ 30,000/mm^3), WHO performance status (0-1 vs 2 vs 3-4), and participating center.

  • Phase II: Patients are randomized to 1 of 3 treatment arms.
  • Arm I: Patients receive gemtuzumab ozogamicin (GO) IV over 2 hours on days 1 and 8. Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive GO IV over 2 hours on days 1, 3, and 5. Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive standard supportive care.
  • Phase III: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive the selected treatment (arm I or arm II) from phase II.
  • Arm II: Patients receive standard supportive care. Patients who receive GO treatment are followed monthly for 1 year and then every 3 months thereafter. Patients who receive standard supportive care are followed at least every 4 weeks.

PROJECTED ACCRUAL: A total of 259 patients (75 for phase II [25 per treatment arm] and 184 for phase III [92 per treatment arm]) will be accrued for this study within 2.5 years.

Conditions
Leukemia
Being tested
gemtuzumab ozogamicin
Keywords
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), untreated adult acute myeloid leukemia, secondary acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)
Medical subject headings
Leukemia, Congenital Abnormalities, Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute

What participants receive

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

  • gemtuzumab ozogamicinDrug

What is being measured

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

  1. Proportion of patients able to start continuation therapy (Phase II)

  2. Overall survival (Phase III)

Secondary outcomes (6)

  1. Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II)

  2. Overall survival (Phase II)

  3. Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III)

  4. Rate of complete remisison (CR+CRp) by the end of induction and by the end of continuation therapy, for patients in GO arm (Phase III)

  5. Disease-free survival for patients who reached CR or CRp (Phase III)

  6. Progression-free survival from randomization for patients in GO arm (Phase III)

Timeline

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

  1. First posted9 Sep 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionDec 2013 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
279 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091234
Sponsor's protocol ID
EORTC-06031
Other IDs
EORTC-06031
Acronym
AML-19
Status last verified
Jul 2012
First submitted
7 Sep 2004
Last updated
24 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Amadori S, Suciu S, Selleslag D, et al.: Phase II-III study of gemtuzumab ozogamicin monotherapy versus best supportive care in older patients with newly diagnosed AML unfit for intensive chemotherapy: first results of the EORTC-GIMEMA AML-19 trial. [Abstract] Blood 112 (11): A-762, 2008.

  • Amadori S, Suciu S, Selleslag D, Aversa F, Gaidano G, Musso M, Annino L, Venditti A, Voso MT, Mazzone C, Magro D, De Fabritiis P, Muus P, Alimena G, Mancini M, Hagemeijer A, Paoloni F, Vignetti M, Fazi P, Meert L, Ramadan SM, Willemze R, de Witte T, Baron F. Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial. J Clin Oncol. 2016 Mar 20;34(9):972-9. doi: 10.1200/JCO.2015.64.0060. Epub 2016 Jan 25.

    PubMed 26811524

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing gemtuzumab ozogamicin in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 45 sites in 3 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: status not confirmed, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Italy, Belgium, Netherlands. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Results are not available in the source record.

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

Contact Hilde Breyssens (hilde.breyssens@eortc.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients able to start continuation therapy (Phase II). The study lists 2 primary outcomes in all. 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 NCT00091234, which also lists 2 linked publications.

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 24 Jul 2012.

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