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NCT02091245 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Refractory Acute Lymphoblastic Leukemia (ALL) and Relapsed Acute Lymphoblastic Leukemia (ALL), sponsored by Dana-Farber Cancer Institute.

Active
Registry status
Phase 1
Development phase
16
Enrollment target
10
Study locations

NCT02091245: Active Phase 1 study of Refractory Acute Lymphoblastic Leukemia (ALL) and Relapsed Acute Lymphoblastic Leukemia (ALL), sponsored by Dana-Farber Cancer Institute.

NCT02091245 is a Phase 1 study of Refractory Acute Lymphoblastic Leukemia (ALL) and Relapsed Acute Lymphoblastic Leukemia (ALL) that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02091245, a Phase 1 study of Refractory Acute Lymphoblastic Leukemia (ALL) and Relapsed Acute Lymphoblastic Leukemia (ALL), is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
16 participants
Enrollment target
10
Study locations

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.

Primary Outcome

Toxicities will be tabulated by type and grade.

Interventions

  • DRUG KPT-330

Study Locations (10)

Massachusetts

  • Boston Children's Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

California

  • UCSF - San Francisco

Colorado

  • Children's Hospital Colorado - Aurora

Georgia

  • Children's Healthcare of Atlanta - Atlanta

New York

  • Columbia University Medical Center - New York

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Texas

  • Texas Children's Hospital - Houston

Washington

  • Seattle Children's Hospital - Seattle

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2014-03
Est. Completion 2026-06
Phase Phase 1
Dana-Farber Cancer Institute

781 total trials

What the registry record for NCT02091245 still lists

NCT02091245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 9 conditions, with Refractory Acute Lymphoblastic Leukemia (ALL) appearing as the primary indexed condition, and to 1 intervention - of which KPT-330 is the first listed.

NCT02091245 lists 10 locations in 9 states (Massachusetts, California, Colorado).

Frequently Asked Questions

What is clinical trial NCT02091245 about?

NCT02091245 is a clinical study titled "Phase I Trial of the Selective Inhibitor of Nuclear Export, KPT-330, in Relapsed Childhood ALL and AML". 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...

What is the current status of trial NCT02091245?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-03. Estimated completion is 2026-06.

What conditions does trial NCT02091245 study?

This clinical trial studies the following conditions: Refractory Acute Lymphoblastic Leukemia (ALL), Relapsed Acute Lymphoblastic Leukemia (ALL), Relapsed Acute Myelogenous Leukemia (AML), Refractory Acute Myelogenous Leukemia (AML), Relapsed Mixed Lineage Leukemia.

What interventions are being tested in trial NCT02091245?

The interventions under investigation include: KPT-330 (DRUG).

Who is sponsoring clinical trial NCT02091245?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02091245 being conducted?

This trial has 10 study locations across California, Colorado, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Refractory Acute Lymphoblastic Leukemia (ALL)

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 NCT02091245's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02091245, the US trial registry maintained by the National Library of Medicine. NCT02091245 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.