Clinical trial
S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine…
NCT00085709 · SWOG Cancer Research Network, Other · Completed
Key facts
| NCT number | NCT00085709 |
|---|---|
| Title | S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML |
| Official title | A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No… |
| Lead sponsor | SWOG Cancer Research Network, Other |
| Collaborators | National Cancer Institute (NCI) NIH |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Leukemia |
| Intervention type | Drug, Other |
| Interventions | gemtuzumab ozogamicin, observation, Cytosine arabinoside, Daunomycin |
| Enrollment | 637 |
| Start date | Jul 1, 2004 |
| Primary completion | Mar 1, 2010 |
| Completion | Aug 1, 2014 |
| First posted | Jun 16, 2004 |
| Last update posted | Sep 30, 2015 |
| Countries | Canada, Sweden, United States |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: