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NCT03817398
Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia
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.
30 June 2026
Quick facts
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 8 November 2019 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 173 locations across Canada, United States, Australia, Puerto Rico |
Drugs / interventions tested
- Biospecimen Collection — full drug profile →
- Drug Withdrawn
- Quality-of-Life Assessment
- Questionnaire Administration
- Tyrosine Kinase Inhibitor — full drug profile →
Conditions studied
- Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive — all drugs for Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03817398
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
Currently open trials in the same condition.
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Other Children's Oncology Group trials
Trials by the same sponsor.
- NCT07412002 — Quality of End-of-Life Care for Children With Cancer · not yet recruiting
- NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant · Phase 1 · withdrawn
- NCT07022678 — Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia · Phase 3 · not yet recruiting
- NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
- NCT07466316 — A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Ove · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03817398 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Oncology Group
- Last refreshed: 13 April 2026
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