TriangleNCT00091234 · CITED IN SOURCE DOCUMENTS
Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2, PHASE3
- Status at capture
- UNKNOWN
- Registry last update
- 2012-07-24
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.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 61 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- interventions
- name
- gemtuzumab ozogamicin
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 279
- type
- ESTIMATED
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Proportion of patients able to start continuation therapy (Phase II)
- measure
- Overall survival (Phase III)
- secondary Outcomes
- measure
- Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II)
- measure
- Overall survival (Phase II)
- measure
- Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III)
- measure
- 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)
- measure
- Disease-free survival for patients who reached CR or CRp (Phase III)
- measure
- Progression-free survival from randomization for patients in GO arm (Phase III)
Full 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.
Source references
- references
- 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.
- type
- RESULT
- 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.
- pmid
- 26811524
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- Analysis Set) Study AAML0531 Trial Abbreviations: GO=gemtuzumab ozogamicin. Figure 2 Study AML-19 MYLOTARG single-agent therapy was evaluated in Study AML-19 (NCT00091234), a multicenter, randomized, open-label Phase 3 study comparing MYLOTARG to best supportive care (BSC) for patients with newly-diagnosed AML who were a) greate
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Preserved source evidence · Not medical advice