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Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (AML-19)

Primary Purpose

Leukemia

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
gemtuzumab ozogamicin
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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)

Eligibility Criteria

61 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Netwerk Antwerpen MiddelheimRecruiting
  • AZ Sint-JanRecruiting
  • Institut Jules BordetRecruiting
  • Hopital Universitaire ErasmeRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • CHU Liege - Domaine Universitaire du Sart TilmanRecruiting
  • Centre Hospitalier Peltzer-La TourelleRecruiting
  • Ospedale S Donato, USL-8Recruiting
  • Universita Degli Studi di BariRecruiting
  • Universita Di BresciaRecruiting
  • Ospedale BinaghiRecruiting
  • Ospedale Oncologico A. BusincoRecruiting
  • Ospedale Regionale A PuglieseRecruiting
  • Ospedale FerrarottoRecruiting
  • Ospedale Regionale A. PuglieseRecruiting
  • Universita di FerraraRecruiting
  • Azienda Ospedaliera Vito FazziRecruiting
  • Azienda Ospedaliera - Universitaria di ModenaRecruiting
  • Ospedale Di MontefiasconeRecruiting
  • Azienda Ospedaliera di Rilievo Nazionale A.CardarelliRecruiting
  • Ospedale Maggiore della CaritaRecruiting
  • Azienda Ospedaliera Policlinico Paolo GiacconeRecruiting
  • Ospedale La Maddalena - PalermoRecruiting
  • Azienda Ospedaliera Di ParmaRecruiting
  • Policlinico MonteluceRecruiting
  • Ospedale San SalvatoreRecruiting
  • Ospedale Civile PescaraRecruiting
  • Ospedale San CarloRecruiting
  • Ospedale Sta. Maria Delle CrociRecruiting
  • Ospedale Sant'AndreaRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Tor VergataRecruiting
  • Ospedale Sant' EugenioRecruiting
  • Libero Istituto Universitario Campus Bio-MedicoRecruiting
  • Azienda Policlinico Umberto PrimoRecruiting
  • Istituto Regina ElenaRecruiting
  • Policlinico A. Gemelli - Universita Cattolica del Sacro CuoreRecruiting
  • H. San Giovanni-Addolorata HospitalRecruiting
  • Universita Degli Studi "La Sapeinza"Recruiting
  • Istituto di Ematologia Universita - University di SassariRecruiting
  • Universita di SienaRecruiting
  • Ospedale Maggiore dell' UniversitaRecruiting
  • Jeroen Bosch ZiekenhuisRecruiting
  • Onze Lieve Vrouwe GasthuisRecruiting
  • Leiden University Medical CenterRecruiting
  • Universitair Medisch Centrum St. Radboud - NijmegenRecruiting

Outcomes

Primary Outcome Measures

Proportion of patients able to start continuation therapy (Phase II)
Overall survival (Phase III)

Secondary Outcome Measures

Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II)
Overall survival (Phase II)
Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III)
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)
Disease-free survival for patients who reached CR or CRp (Phase III)
Progression-free survival from randomization for patients in GO arm (Phase III)

Full Information

First Posted
September 7, 2004
Last Updated
July 23, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT00091234
Brief Title
Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Acronym
AML-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
279 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemtuzumab ozogamicin
Primary Outcome Measure Information:
Title
Proportion of patients able to start continuation therapy (Phase II)
Title
Overall survival (Phase III)
Secondary Outcome Measure Information:
Title
Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II)
Title
Overall survival (Phase II)
Title
Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III)
Title
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)
Title
Disease-free survival for patients who reached CR or CRp (Phase III)
Title
Progression-free survival from randomization for patients in GO arm (Phase III)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilde Breyssens
Email
hilde.breyssens@eortc.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Amadori, MD
Organizational Affiliation
EORTC - AZIENDA OSPEDALLERA UNIVERSITARIA - POLICLINICO TOR VERGATA, IT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuliana Alimena
Organizational Affiliation
GIMEMA - Universita Degli Studi "La Sapeinza"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
32-3-280-3111
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
32-50-45-2111
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
32-2-541-3510
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
32-2-555-3806
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
32-03-821-3375
Facility Name
CHU Liege - Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
32-4-366-7111
Facility Name
Centre Hospitalier Peltzer-La Tourelle
City
Verviers
ZIP/Postal Code
B-4800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
328-721-2111
Facility Name
Ospedale S Donato, USL-8
City
Arezzo cap
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita Degli Studi di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-080-547-8660
Facility Name
Universita Di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Binaghi
City
Cagliari
ZIP/Postal Code
090100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-070-609-3149
Facility Name
Ospedale Oncologico A. Businco
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-070-609-5204
Facility Name
Ospedale Regionale A Pugliese
City
Cantanzaro
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Ferrarotto
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-095-743-5915
Facility Name
Ospedale Regionale A. Pugliese
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-961-883-346
Facility Name
Universita di Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-532-209-100
Facility Name
Azienda Ospedaliera Vito Fazzi
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-083-266-1235
Facility Name
Azienda Ospedaliera - Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-059-422-4373
Facility Name
Ospedale Di Montefiascone
City
Montefiascone
ZIP/Postal Code
I-01027
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-07-618-331
Facility Name
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
City
Naples
ZIP/Postal Code
80127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-081-747-3011
Facility Name
Ospedale Maggiore della Carita
City
Novara
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-091-655-2321
Facility Name
Ospedale La Maddalena - Palermo
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-91-680-6111
Facility Name
Azienda Ospedaliera Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-0521-702-441
Facility Name
Policlinico Monteluce
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo F. Martelli, MD
Phone
39-75-5783219
Email
ematol@unipg.it
Facility Name
Ospedale San Salvatore
City
Pesaro
ZIP/Postal Code
I-61100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G. Lucarelli
Phone
0039-0721-36424
Facility Name
Ospedale Civile Pescara
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Facility Name
Ospedale San Carlo
City
Potenza
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Sta. Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-544-285-247
Facility Name
Ospedale Sant'Andrea
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-06-20-901
Facility Name
Ospedale Sant' Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-06-5100-2569
Facility Name
Libero Istituto Universitario Campus Bio-Medico
City
Rome
ZIP/Postal Code
00155
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact
Phone
39-06-2254-1366
Facility Name
Azienda Policlinico Umberto Primo
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Mandelli
Phone
39-06-85-79-51
Facility Name
Istituto Regina Elena
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-06-4985-2201
Facility Name
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-06-3015-5556
Facility Name
H. San Giovanni-Addolorata Hospital
City
Rome
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Facility Name
Universita Degli Studi "La Sapeinza"
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuliana Alimena
Phone
39-06-857-951
Facility Name
Istituto di Ematologia Universita - University di Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-79-228-280
Facility Name
Universita di Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-0577-586-429
Facility Name
Ospedale Maggiore dell' Universita
City
Trieste
ZIP/Postal Code
34100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
39-040-399-2232
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
31-73-699-2000
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
31-20-599-9111
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
31-71-526-9111
Facility Name
Universitair Medisch Centrum St. Radboud - Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
26811524
Citation
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. Erratum In: J Clin Oncol. 2022 Feb 10;40(5):525.
Results Reference
derived

Learn more about this trial

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

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