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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: Completed Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by St. Jude Children's Research Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The MTD is empirically defined as the highest dose level at which six participants have been treated with at most one participant experiencing a DLT and the next higher dose has been determined to be too toxic. If the lowest dose level studied is too toxic or the highest dose level studied is considered safe, the MTD will not have been considered estimated.

Conditions Studied

Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS) Acute Lymphoblastic Leukemia (ALL) Mixed Phenotype Acute Leukemia (MPAL)

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

FieldValue
Enrollment Target 19 participants
Start Date 2014-08
Est. Completion 2015-12
Phase Phase 1
St. Jude Children's Research Hospital

410 total trials

What the finished NCT02212561 record still lists

NCT02212561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 145-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (87% lower).

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 lists 6 locations in 6 states (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.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia (AML)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02212561's enrollment target sits among peer trials

19 25th of 29 higher than 5 of 29 other Acute Myeloid Leukemia (AML) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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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Related registry views

Source: ClinicalTrials.gov NCT02212561, the US trial registry maintained by the National Library of Medicine. NCT02212561 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.