deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT02212561

Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

Sponsor: Karyopharm Therapeutics Inc

Conditions Acute Lymphoblastic Leukemia (ALL) Acute Myeloid Leukemia (AML) Mixed Phenotype Acute Leukemia (MPAL) Myelodysplastic Syndrome (MDS)
Interventions Cytarabine Fludarabine Selinexor methotrexate/hydrocortisone/cytarabine
Updated 9 times since 2017 Last updated: Mar 25, 2020 Started: Aug 31, 2014 Primary completion: Dec 31, 2015 Completion: Dec 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML), this trial is completed. The trial is conducted by Karyopharm Therapeutics Inc and has accumulated 9 data snapshots since 2014. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshotRecruiting~Mar 2017 – ~May 2017 · 2 months · monthly snapshotCompleted~May 2017 – ~Jun 2018 · 13 months · monthly snapshotCompleted~Jun 2018 – ~Apr 2020 · 22 months · monthly snapshotCompleted~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Apr 2020 — Jan 2021 [monthly]

    Completed PHASE1

  5. Jun 2018 — Apr 2020 [monthly]

    Completed PHASE1

▶ Show 4 earlier versions

  1. May 2017 — Jun 2018 [monthly]

    Completed PHASE1

  2. Mar 2017 — May 2017 [monthly]

    Completed PHASE1

    Status: Recruiting → Completed · Phase: PHASE1_PHASE2 → PHASE1

  3. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Aug 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Karyopharm Therapeutics Inc
  • St. Jude Children's Research Hospital
Data source: St. Jude Children's Research Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations