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NCT02212561 · ClinicalTrials.gov registry record · Phase 1
Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome
A Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 6
- Study locations
NCT02212561 is a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 19 participants, below the 145-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (87% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT02212561, a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to test the safety of selinexor (KPT-330) and to find the highest dose of selinexor (KPT-330) that can be given safely when it is combined with two chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase I and Phase II. The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine. The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) 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 leukemia or MDS. The investigators will examine the effect of this combination treatment. PRIMARY OBJECTIVE: * Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric patients with relapsed or refractory hematologic malignancies included acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia (MPAL) and myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: * To characterize the pharmacokinetics of selinexor, when administered in tablet form, after the first dose and at steady-state, as well as in combination with fludarabine and cytarabine * To estimate the overall response rate of selinexor given with fludarabine and cytarabine in patients with relapsed or refractory hematologic malignancies
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Selinexor
- DRUG Cytarabine
- DRUG methotrexate/hydrocortisone/cytarabine
Study Locations (6)
Arizona
- Phoenix Children's Hospital - Phoenix
California
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Illinois
- University of Chicago - Chicago
North Carolina
- Duke University Medical Center - Durham
Tennessee
- St. Jude Children's Research Hospital - Memphis
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02212561
The ClinicalTrials.gov registry entry for NCT02212561 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 145-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (87% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.
NCT02212561 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Arizona, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT02212561 about?
NCT02212561 is a clinical study titled "Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome". The purpose of this study is to test the safety of selinexor (KPT-330) and to find the highest dose of selinexor (KPT-330) that can be given safely when it is combined with two chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase I and Phase II. The goal of P...
What is the current status of trial NCT02212561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2014-08. Estimated completion is 2015-12.
What conditions does trial NCT02212561 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Acute Lymphoblastic Leukemia (ALL), Mixed Phenotype Acute Leukemia (MPAL).
What interventions are being tested in trial NCT02212561?
The interventions under investigation include: Fludarabine (DRUG), Selinexor (DRUG), Cytarabine (DRUG), methotrexate/hydrocortisone/cytarabine (DRUG).
Who is sponsoring clinical trial NCT02212561?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02212561 being conducted?
This trial has 6 study locations across Arizona, California, Illinois, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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