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NCT03071276 · ClinicalTrials.gov registry record · Phase 2
Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT03071276 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 37 participants.
The verdict
NCT03071276, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study will be done in two parts: Phase I (NCT02212561) has been completed and published. The goal of the Phase I portion of this study was to find the highest tolerable dose of selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome (MDS), when it is combined with fludarabine and cytarabine. The Phase II portion of the protocol is reflected in this registration. The goal of the Phase II portion of this protocol is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with acute myeloid leukemia (AML). The investigators will examine the effect of this combination treatment.
Interventions
- DRUG Fludarabine
- DRUG Selinexor
- DRUG Cytarabine
- DRUG methotrexate/hydrocortisone/cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-01-14 |
| Est. Completion | 2019-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03071276
The ClinicalTrials.gov registry entry for NCT03071276 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT03071276 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03071276 about?
NCT03071276 is a clinical study titled "Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia". This study will be done in two parts: Phase I (NCT02212561) has been completed and published. The goal of the Phase I portion of this study was to find the highest tolerable dose of selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome (MDS), when it is combined...
What is the current status of trial NCT03071276?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2016-01-14. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT03071276?
The interventions under investigation include: Fludarabine (DRUG), Selinexor (DRUG), Cytarabine (DRUG), methotrexate/hydrocortisone/cytarabine (DRUG).
Who is sponsoring clinical trial NCT03071276?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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