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NCT00085709 · ClinicalTrials.gov registry record · Phase 3
S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 637
- Enrollment target
NCT00085709: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT00085709 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 637 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00085709, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 637 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. 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. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia. PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.
Primary Outcome
Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.
Interventions
- OTHER observation
- DRUG gemtuzumab ozogamicin
- DRUG Daunomycin
- DRUG Cytosine arabinoside
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2004-07 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT00085709 record still lists
NCT00085709 is an interventional study that assigns participants to a tested intervention. The registered 637 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 4 interventions - of which observation is the first listed.
NCT00085709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00085709 about?
NCT00085709 is a clinical study titled "S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML". RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances ...
What is the current status of trial NCT00085709?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2004-07. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00085709?
The interventions under investigation include: observation (OTHER), gemtuzumab ozogamicin (DRUG), Daunomycin (DRUG), Cytosine arabinoside (DRUG).
Who is sponsoring clinical trial NCT00085709?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00085709's enrollment target sits among peer trials
637 579th of 2000 higher than 1,422 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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