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NCT02416908 · ClinicalTrials.gov registry record · Phase 1
Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02416908 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 40 participants.
The verdict
NCT02416908, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Selinexor has shown single-agent activity in a current phase I study enrolling patients with relapsed/refractory AML with durable complete remissions (CR), complete remissions with incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD) observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen without significant non-hematologic toxicity. Given the established role of CLAG chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities, the investigators propose a phase I/II open label study of selinexor in combination with CLAG for the treatment of patients with relapsed/refractory AML.
Interventions
- DRUG Cladribine
- DRUG Selinexor
- DRUG G-CSF
- DRUG Cytarabine
- PROCEDURE Bone marrow biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-06-16 |
| Est. Completion | 2019-06-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02416908
The ClinicalTrials.gov registry entry for NCT02416908 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cladribine is the first listed.
NCT02416908 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02416908 about?
NCT02416908 is a clinical study titled "Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia". Selinexor has shown single-agent activity in a current phase I study enrolling patients with relapsed/refractory AML with durable complete remissions (CR), complete remissions with incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD) observed. Furthermore, common t...
What is the current status of trial NCT02416908?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2015-06-16. Estimated completion is 2019-06-21.
What interventions are being tested in trial NCT02416908?
The interventions under investigation include: Cladribine (DRUG), Selinexor (DRUG), G-CSF (DRUG), Cytarabine (DRUG), Bone marrow biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02416908?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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