TriangleNCT00927498 · CITED IN SOURCE DOCUMENTS
A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2013-07-11
The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.
Open the original ClinicalTrials.gov record → · Download preserved record
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
- Inclusion Criteria: * Patients with a morphologically proven diagnosis AML and both the two following criteria: Age \> 50 years and £ 70 years. Not previously treated for their disease. * ECOG performance status 0 to 3 * Negative serology HIV, HBV and HBC (except post vaccination) * Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N * Cardiac function determined by radionucleide or echography within normal limits. * Negative serum pregnancy test within one week before treatment for women of child bearing potential. * Signed informed consent. Exclusion Criteria: * M3-AML * AML following previously know myeloproliferative syndrome. * Known central nervous system involvement. * Uncontrolled infection * Other active malignancy
- healthy Volunteers
- false
- maximum Age
- 70 Years
- minimum Age
- 50 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.
- intervention Names
- Drug: conventional chemotherapy (AraC + Daunorubicin),
- label
- Arm A Daunorubicin and Cytarabine
- type
- ACTIVE_COMPARATOR
- description
- Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4. Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.
- intervention Names
- Drug: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
- label
- Arm B Daunorubicin and Cytarabine and Mylotarg
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm A Daunorubicin and Cytarabine
- description
- Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.
- name
- conventional chemotherapy (AraC + Daunorubicin),
- type
- DRUG
- arm Group Labels
- Arm B Daunorubicin and Cytarabine and Mylotarg
- description
- Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4. Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.
- name
- Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 280
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Event Free Survival (EFS)
- time Frame
- Relapse or death measured from randomization
- secondary Outcomes
- measure
- CR rate
- time Frame
- CR after induction
- measure
- Cumulative incidence of relapse
- time Frame
- Relapse from CR
- measure
- Overall Survival
- time Frame
- Survival from randomization
- measure
- Safety of the combination Mylotarg+chemotherapy
- time Frame
- Duration of study
- measure
- Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM)
- time Frame
- Duration of study
- measure
- Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.
- time Frame
- Duration of study
Full study description
- brief Summary
- The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.
- detailed Description
- Patients with a morphologically proven diagnosis AML and both the two following criteria: * Age \> 50 years and £ 70 years. * Not previously treated for their disease. Randomization will be centralized by phone : Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.
Source references
- references
- citation
- Muresan B, Mamolo C, Cappelleri JC, Mokgokong R, Palaka A, Soikkeli F, Heeg B. Comparing cure rates for gemtuzumab ozogamicin plus standard chemotherapy vs standard chemotherapy alone in acute myeloid leukemia patients. Future Oncol. 2021 Aug;17(22):2883-2892. doi: 10.2217/fon-2020-1287. Epub 2021 Apr 16.
- pmid
- 33858190
- type
- DERIVED
- citation
- Renneville A, Abdelali RB, Chevret S, Nibourel O, Cheok M, Pautas C, Dulery R, Boyer T, Cayuela JM, Hayette S, Raffoux E, Farhat H, Boissel N, Terre C, Dombret H, Castaigne S, Preudhomme C. Clinical impact of gene mutations and lesions detected by SNP-array karyotyping in acute myeloid leukemia patients in the context of gemtuzumab ozogamicin treatment: results of the ALFA-0701 trial. Oncotarget. 2014 Feb 28;5(4):916-32. doi: 10.18632/oncotarget.1536.
- pmid
- 24659740
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-4976ae363bd95d83a5f5
- requested nct id
- NCT00927498
- primary nct id
- NCT00927498
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- 8e7cc2e32fc51992c491e61751eea5c12733e2487675051b006bf5d81066b2f7
- payload sha256
- ee554167625c22c33351060245d6a881bd65041fd6c501484c42cbf2c2c6cb7f
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-4976ae363bd95d83a5f5
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00927498
- occurrences
- context exact
- e cytogenetics.</li><li>The evidence for a benefit in patients with <em class="gene-name">FLT3</em> ITD variants was mixed; the French <a href="/clinicaltrials/NCT00927498">ALFA-0701 (NCT00927498)</a> trial showed a trend toward a benefit, whereas the five-trial meta-analysis study did not find a benefit.[<a href="#cit/section_6.
- end
- 359285
- exact text
- NCT00927498
- start
- 359274
- context exact
- The evidence for a benefit in patients with <em class="gene-name">FLT3</em> ITD variants was mixed; the French <a href="/clinicaltrials/NCT00927498">ALFA-0701 (NCT00927498)</a> trial showed a trend toward a benefit, whereas the five-trial meta-analysis study did not find a benefit.[<a href="#cit/section_6.23">23</a>,<a href="#cit
- end
- 359309
- exact text
- NCT00927498
- start
- 359298
- context exact
- ><li> This impact was seen for low-, intermediate-, and high-risk patients.</li></ul></div></li><li>In a retrospective analysis of the <a href="/clinicaltrials/NCT00927498">ALFA-0701 (NCT00927498)</a> trial of older adults, higher CD33 expression corresponded with greater benefit from treatment with gemtuzumab ozogamicin.[<a href
- end
- 361422
- exact text
- NCT00927498
- start
- 361411
- context exact
- en for low-, intermediate-, and high-risk patients.</li></ul></div></li><li>In a retrospective analysis of the <a href="/clinicaltrials/NCT00927498">ALFA-0701 (NCT00927498)</a> trial of older adults, higher CD33 expression corresponded with greater benefit from treatment with gemtuzumab ozogamicin.[<a href="#cit/section_6.25">25<
- end
- 361446
- exact text
- NCT00927498
- start
- 361435
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/73204a34a100b0fa2e.html
- source file sha256
- 8e7cc2e32fc51992c491e61751eea5c12733e2487675051b006bf5d81066b2f7
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:21:53.537755+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- 74fb97edc9145215f8b85c366e8cc116f08a5151772cf550992345b297a46bf0
- source title
- Childhood Acute Myeloid Leukemia Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: April 15, 2025
- datetime
- 2025-04-15T12:00:00Z
- display
- April 15, 2025
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-d34e7bb84f4c00e5846d
- requested nct id
- NCT00927498
- primary nct id
- NCT00927498
- source kind
- fda_spl_label
- source record id
- ef242018-af2a-4c03-99b7-908e2610f86f
- source file sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- payload sha256
- c470880b6075f01c95479e68358404ac865690a8b85511afc4828657f1376d08
- payload
- application numbers
- BLA761060
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-d34e7bb84f4c00e5846d
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00927498
- occurrences
- context exact
- 14 CLINICAL STUDIES 14.1 Newly-Diagnosed CD33-positive AML Study ALFA-0701 MYLOTARG in combination with chemotherapy was evaluated in ALFA-0701 (NCT00927498), a multicenter, randomized, open-label Phase 3 study of 271 patients with newly-diagnosed de novo AML ages 50 to 70 years. Patients were randomized (1:1) to r
- end
- 156
- exact text
- NCT00927498
- start
- 145
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00700.json
- source file sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- source json pointer
- /results/94/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- ef242018-af2a-4c03-99b7-908e2610f86f
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 9c2856af75696d89fa04ccc91a06e5cfe725c13157afa3410f42854f76db2b14
- spl effective time
- 20251219
- spl set id
- 32fd2bb2-1cfa-4250-feb8-d7956c794e05
Preserved source evidence · Not medical advice