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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 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 637 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00085709
The ClinicalTrials.gov registry entry for NCT00085709 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 637 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which observation is the first listed.
NCT00085709 reports 0 study locations.
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.
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