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NCT03817398

Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia

Active, enrolled Phase 2 Last updated 13 April 2026
What this trial tests

Phase 2 trial testing Biospecimen Collection in Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive in 110 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
8 November 2019
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorChildren's Oncology Group
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment110
Start date8 November 2019
Primary completion30 June 2026
Estimated completion30 June 2026
Sites173 locations across Canada, United States, Australia, Puerto Rico

Drugs / interventions tested

Conditions studied

Sponsor

Children's Oncology Group — full company profile →

Who can join

Under 25, any sex, with Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Children's Oncology Group's 2023 blueprint for research: Myeloid neoplasms.
    Cooper TM, Alonzo TA, Tasian SK, Kutny MA, et al · · 2023 · cited 22× · PMID 37480164 · DOI 10.1002/pbc.30584
  2. Children's Oncology Group's 2023 blueprint for research: Diversity and health disparities.
    Winestone LE, Beauchemin MP, Bona K, Kahn J, et al · · 2023 · cited 17× · PMID 37501542 · DOI 10.1002/pbc.30592
  3. Management of Chronic Myeloid Leukemia in Children and Young Adults.
    Ford M, Mauro M, Aftandilian C, Sakamoto KM, et al · · 2022 · cited 12× · PMID 35920965 · DOI 10.1007/s11899-022-00673-5
  4. Progress in precision therapy in pediatric oncology.
    O'Donohue T, Farouk Sait S, Glade Bender J. · · 2023 · cited 6× · PMID 36377257 · DOI 10.1097/mop.0000000000001198
  5. Exploration of treatment-free remission in CML, based on molecular monitoring.
    Zhang Z, Zhou X, Zhou X, Cheng Z, et al · · 2024 · cited 3× · PMID 38133525 · DOI 10.1002/cam4.6849

Verify or expand the search:

Other trials of Biospecimen Collection

Trials testing the same drug.

Other recruiting trials for Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive

Currently open trials in the same condition.

Other Children's Oncology Group trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03817398.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing