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Phase I Trial of the Selective Inhibitor of Nuclear Export, KPT-330, in Relapsed Childhood ALL and AML

NCT02091245 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-02

No results posted yet for this study

Summary

This research study involves participants who have acute lymphoblastic or acute myelogenous leukemia that has relapsed or has become resistant (or refractory) to standard therapies. This research study is evaluating a drug called KPT-330. Laboratory and other studies suggest that the study drug, KPT-330, may prevent leukemia cells from growing and may lead to the destruction of leukemia cells. It is thought that KPT-330 activates cellular processes that increase the death of leukemia cells. The main goal of this study is to evaluate the side effects of KPT-330 when it is administered to children and adolescents with relapsed or refractory leukemia.

Conditions

  • Relapsed Acute Lymphoblastic Leukemia (ALL)
  • Refractory Acute Lymphoblastic Leukemia (ALL)
  • Relapsed Acute Myelogenous Leukemia (AML)
  • Refractory Acute Myelogenous Leukemia (AML)
  • Relapsed Mixed Lineage Leukemia
  • Refractory Mixed Lineage Leukemia
  • Relapsed Biphenotypic Leukemia
  • Refractory Biphenotypic Leukemia
  • Chronic Myelogenous Leukemia (CML) in Blast Crisis

Interventions

DRUG

KPT-330

Sponsors & Collaborators

  • William Lawrence and Blanche Hughes Foundation

    collaborator OTHER

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Andrew E Place, MD,PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-02-28
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091245 on ClinicalTrials.gov