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NCT01404949 · ClinicalTrials.gov registry record · Phase 2
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01404949: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01404949 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01404949, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to find what effects, good and/or bad, treatment with two drugs has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA, or Vesanoid). It is an approved medicine that causes the leukemia cells in APL to mature. It is related to vitamin A. The second is arsenic trioxide (Trisenox). It is an approved medicine for APL that comes back after earlier treatment. APL is most often treated with tretinoin and standard chemotherapy drugs. These chemotherapy drugs can cause infection and bleeding. They can also damage the heart and normal bone marrow cells. This can lead to a second leukemia years later. In this study, the investigators are using tretinoin and arsenic trioxide together. Both drugs work to treat APL. They have been used together in only a limited number of people. The investigators want to use these drugs together to reduce the amount of standard chemotherapy and decrease side effects. The patient will receive standard chemotherapy with a drug called idarubicin only if they have a higher chance of the leukemia coming back or a higher risk of side effects.
Primary Outcome
after induction with combined tretinoin and ATO (along with idarubicin in patients with high-risk disease or who develop leukocytosis) in APL.
Interventions
- DRUG Tretinoin and Arsenic Trioxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-07 |
| Est. Completion | 2021-02-01 |
| Phase | Phase 2 |
What the finished NCT01404949 record still lists
NCT01404949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Tretinoin and Arsenic Trioxide is the first listed.
NCT01404949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01404949 about?
NCT01404949 is a clinical study titled "Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy". The purpose of this study is to find what effects, good and/or bad, treatment with two drugs has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA, or Vesanoid). It is an approved medicine that causes the leukemia cells in APL to mature. It is related to vitamin...
What is the current status of trial NCT01404949?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2011-07. Estimated completion is 2021-02-01.
What interventions are being tested in trial NCT01404949?
The interventions under investigation include: Tretinoin and Arsenic Trioxide (DRUG).
Who is sponsoring clinical trial NCT01404949?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01404949's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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