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NCT01850004 · ClinicalTrials.gov registry record · Phase 2

Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response

A Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target
20
Study locations

NCT01850004: Completed Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, sponsored by Bristol-Myers Squibb.

NCT01850004 is a Phase 2 study of Chronic Phase Chronic Myeloid Leukemia that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01850004, a Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target
20
Study locations

Study Summary

The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.

Primary Outcome

Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts \< 0.1% on the International Scale \[IS\]) at 12 months after Dasatinib discontinuation without restarting Dasatinib

Interventions

  • DRUG Dasatinib

Study Locations (20)

Other

  • Local Institution - 0012 - Paris
  • Local Institution - 0003 - Pessac
  • Local Institution - 0030 - Pierre-Bénite
  • Local Institution - 0002 - Vandœuvre-lès-Nancy
  • Local Institution - 0026 - Aachen
  • Local Institution - 0020 - Berlin
  • Local Institution - 0021 - Mannheim
  • Local Institution - 0022 - Ulm
  • Local Institution - 0025 - Catania
  • Local Institution - 0017 - Florence

California

  • Local Institution - 0006 - Duarte
  • Local Institution - 0029 - Los Angeles
  • Local Institution - 0001 - San Franisco

Texas

  • Local Institution - 0011 - Dallas
  • Local Institution - 0023 - Houston

Illinois

  • Local Institution - 0013 - Chicago

New Jersey

  • Local Institution - 0024 - Hackensack

New York

  • Local Institution - 0028 - New York

Ontario

  • Local Institution - 0005 - Toronto

Mecklenburg-Vorpommern

  • Local Institution - 0019 - Rostock

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2014-01-22
Est. Completion 2021-10-08
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01850004 record still lists

NCT01850004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).

The record links to 1 condition, with Chronic Phase Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Dasatinib is the first listed.

NCT01850004 names 20 study sites across 8 states, led by Other, California, Texas.

Frequently Asked Questions

What is clinical trial NCT01850004 about?

NCT01850004 is a clinical study titled "Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response". The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL r...

What is the current status of trial NCT01850004?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2014-01-22. Estimated completion is 2021-10-08.

What conditions does trial NCT01850004 study?

This clinical trial studies the following conditions: Chronic Phase Chronic Myeloid Leukemia.

What interventions are being tested in trial NCT01850004?

The interventions under investigation include: Dasatinib (DRUG).

Who is sponsoring clinical trial NCT01850004?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01850004 being conducted?

This trial has 20 study locations across California, Illinois, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Chronic Phase Chronic Myeloid Leukemia

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 NCT01850004's enrollment target sits among peer trials

84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01850004, the US trial registry maintained by the National Library of Medicine. NCT01850004 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.