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NCT01802333 · ClinicalTrials.gov registry record · Phase 3
Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 754
- Enrollment target
NCT01802333: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01802333 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 754 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802333, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 754 participants
- Enrollment target
Study Summary
This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.
Primary Outcome
EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. 2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Daunorubicin Hydrochloride
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 754 participants |
| Start Date | 2013-02-12 |
| Est. Completion | 2017-06-15 |
| Phase | Phase 3 |
What the finished NCT01802333 record still lists
NCT01802333 is an interventional study that assigns participants to a tested intervention. The registered 754 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01802333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01802333 about?
NCT01802333 is a clinical study titled "Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia". This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubi...
What is the current status of trial NCT01802333?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 754 participants. The study started on 2013-02-12. Estimated completion is 2017-06-15.
What interventions are being tested in trial NCT01802333?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Idarubicin (DRUG), Daunorubicin Hydrochloride (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01802333?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01802333's enrollment target sits among peer trials
754 460th of 2000 higher than 1,541 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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