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NCT00091234

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

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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

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Leukemia

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gemtuzumab ozogamicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergio Amadori, MD

Role: PRINCIPAL_INVESTIGATOR

EORTC - AZIENDA OSPEDALLERA UNIVERSITARIA - POLICLINICO TOR VERGATA, IT

Giuliana Alimena

Role: PRINCIPAL_INVESTIGATOR

GIMEMA - Universita Degli Studi "La Sapeinza"

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Belgium Italy Netherlands

Central Contacts

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Hilde Breyssens

Other Identifiers

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EORTC-06031

Identifier Type: -

Identifier Source: secondary_id

EORTC-06031

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

gemtuzumab ozogamicin

Eligibility Criteria

Inclusion Criteria

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

European Organisation for Research and Treatment of Cancer - EORTC

Responsible Party

Principal Investigators

Sergio Amadori, MD

Giuliana Alimena

Locations

Ziekenhuis Netwerk Antwerpen Middelheim

AZ Sint-Jan

Institut Jules Bordet

Hopital Universitaire Erasme

Universitair Ziekenhuis Antwerpen

CHU Liege - Domaine Universitaire du Sart Tilman

Centre Hospitalier Peltzer-La Tourelle

Ospedale S Donato, USL-8

Universita Degli Studi di Bari

Universita Di Brescia

Ospedale Binaghi

Ospedale Oncologico A. Businco

Ospedale Regionale A Pugliese

Ospedale Ferrarotto

Ospedale Regionale A. Pugliese

Universita di Ferrara

Azienda Ospedaliera Vito Fazzi

Azienda Ospedaliera - Universitaria di Modena

Ospedale Di Montefiascone

Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

Ospedale Maggiore della Carita

Azienda Ospedaliera Policlinico Paolo Giaccone

Ospedale La Maddalena - Palermo

Azienda Ospedaliera Di Parma

Policlinico Monteluce

Ospedale San Salvatore

Ospedale Civile Pescara

Ospedale San Carlo

Ospedale Sta. Maria Delle Croci

Ospedale Sant'Andrea

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Ospedale Sant' Eugenio

Libero Istituto Universitario Campus Bio-Medico

Azienda Policlinico Umberto Primo

Istituto Regina Elena

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

H. San Giovanni-Addolorata Hospital

Universita Degli Studi "La Sapeinza"

Istituto di Ematologia Universita - University di Sassari

Universita di Siena

Ospedale Maggiore dell' Universita

Jeroen Bosch Ziekenhuis

Onze Lieve Vrouwe Gasthuis

Leiden University Medical Center

Universitair Medisch Centrum St. Radboud - Nijmegen

Countries

Central Contacts

Hilde Breyssens

Facility Contacts

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