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

NCT00091234 | Unknown Phase 2 DMC

• 1 other identifier: EORTC-06031
• Study Type: interventional
• Target: 279
• Locations: 3 countries
• Sites: 45

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.

Conditions

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)

Outcome Measures

Primary Outcomes (2)

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

• Overall survival (Phase III)

Secondary Outcomes (6)

• 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)

Interventions

gemtuzumab ozogamicin DRUG

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Gruppo Italiano Malattie EMatologiche dell'Adulto: collaborator

Study Sites (45)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

RECRUITING

AZ Sint-Jan

Bruges, 8000, Belgium

RECRUITING

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Hopital Universitaire Erasme

Brussels, 1070, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

RECRUITING

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

RECRUITING

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

RECRUITING

Ospedale S Donato, USL-8

Arezzo Cap, Italy

RECRUITING

Universita Degli Studi di Bari

Bari, 70124, Italy

RECRUITING

Universita Di Brescia

Brescia, Italy

RECRUITING

Ospedale Binaghi

Cagliari, 090100, Italy

RECRUITING

Ospedale Oncologico A. Businco

Cagliari, 09121, Italy

RECRUITING

Ospedale Regionale A Pugliese

Cantanzaro, Italy

RECRUITING

Ospedale Ferrarotto

Catania, 95124, Italy

RECRUITING

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

RECRUITING

Universita di Ferrara

Ferrara, 44100, Italy

RECRUITING

Azienda Ospedaliera Vito Fazzi

Lecce, 73100, Italy

RECRUITING

Azienda Ospedaliera - Universitaria di Modena

Modena, 41100, Italy

RECRUITING

Ospedale Di Montefiascone

Montefiascone, I-01027, Italy

RECRUITING

Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

Naples, 80127, Italy

RECRUITING

Ospedale Maggiore della Carita

Novara, Italy

RECRUITING

Azienda Ospedaliera Policlinico Paolo Giaccone

Palermo, 90127, Italy

RECRUITING

Ospedale La Maddalena - Palermo

Palermo, Italy

RECRUITING

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

RECRUITING

Policlinico Monteluce

Perugia, 06122, Italy

RECRUITING

Ospedale San Salvatore

Pesaro, I-61100, Italy

RECRUITING

Ospedale Civile Pescara

Pescara, 65100, Italy

RECRUITING

Ospedale San Carlo

Potenza, Italy

RECRUITING

Ospedale Sta. Maria Delle Croci

Ravenna, 48100, Italy

RECRUITING

Ospedale Sant'Andrea

Roma, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, 00133, Italy

RECRUITING

Ospedale Sant' Eugenio

Rome, 00144, Italy

RECRUITING

Libero Istituto Universitario Campus Bio-Medico

Rome, 00155, Italy

RECRUITING

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

RECRUITING

Istituto Regina Elena

Rome, 00161, Italy

RECRUITING

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

RECRUITING

H. San Giovanni-Addolorata Hospital

Rome, 00184, Italy

RECRUITING

Universita Degli Studi "La Sapeinza"

Rome, Italy

RECRUITING

Istituto di Ematologia Universita - University di Sassari

Sassari, 07100, Italy

RECRUITING

Universita di Siena

Siena, 53100, Italy

RECRUITING

Ospedale Maggiore dell' Universita

Trieste, 34100, Italy

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

RECRUITING

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

RECRUITING

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

RECRUITING

Related Publications (2)

• 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.

  RESULT

• 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.

  PMID: 26811524 DERIVED

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sergio Amadori, MD

  EORTC - AZIENDA OSPEDALLERA UNIVERSITARIA - POLICLINICO TOR VERGATA, IT

  PRINCIPAL INVESTIGATOR

• Giuliana Alimena

  GIMEMA - Universita Degli Studi "La Sapeinza"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilde Breyssens

CONTACT

hilde.breyssens@eortc.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 9, 2004
• Study Start: June 1, 2004
• Primary Completion: December 1, 2013
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

BE (7); NL (4); IT (34)