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NCT02752035 · ClinicalTrials.gov registry record · Phase 3
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 183
- Enrollment target
NCT02752035: Completed Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT02752035 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 183 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02752035, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 183 participants
- Enrollment target
Study Summary
This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some participants with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster. For participants with AML who could not receive standard chemotherapy, azacitidine (also known as Vidaza®) was a current standard of care treatment option in the United States. This clinical study tested an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib worked by stopping the leukemia cells from making the FLT3 protein. This helped stop the leukemia cells from growing faster. This study compared two different treatments. Participants were assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There was a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.
Primary Outcome
OS was defined as the time from the date of randomization until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. Kaplan-Meier (KM) estimates was used for analysis.
Interventions
- DRUG azacitidine
- DRUG gilteritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 3 |
What the finished NCT02752035 record still lists
NCT02752035 is an interventional study that assigns participants to a tested intervention. The registered 183 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which azacitidine is the first listed.
NCT02752035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02752035 about?
NCT02752035 is a clinical study titled "A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy". This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some participants with AML have a mutation, or change, in the...
What is the current status of trial NCT02752035?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 183 participants. The study started on 2016-08-01. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT02752035?
The interventions under investigation include: azacitidine (DRUG), gilteritinib (DRUG).
Who is sponsoring clinical trial NCT02752035?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02752035's enrollment target sits among peer trials
183 1420th of 2000 higher than 580 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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