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Evaluating Treatment-Free Remission in Indian Children with Chronic Myeloid Leukemia: A Multicenter Study on Stopping TKI Therapy

Stopping Tyrosine Kinase Inhibitors in Children with Chronic Myeloid Leukemia in Chronic Phase: A Multicenter Prospective Trial of the Indian Pediatric Hematology Oncology Group - The STIC-CML Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/109406
Enrollment
115
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil Intervention6: Nil: Nil Intervention7: Nil: Nil Intervention8: Nil: Nil Interven

Sponsors

TMH PAREL ,MUMBAI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Age less than 15 years at the time of diagnosis of CML 2-Patients with chronic-phase CML at the time of diagnosis 3-Treated with Any TKI for more than or equal to 3 years years 4-Sustained Deep Molecular Response DMR (Continuous documented BCR- ABL1 less than 0.01percent International Standardized by real-time quantitative polymerase chain reaction (RQ-PCR) for greater than or equal to 2 years 5-Patients currently on TKI therapy will be eligible for enrolment once they meet all inclusion criteria, including a minimum of 3 years of continuous TKI therapy and 2 years of sustained DMR at the time of enrolment Since this is a multicenter study, other participating centers may include patients up to 18 years as per their local definition of the pediatric population.

Exclusion criteria

Exclusion criteria: 1-Patient who has received more than 1 line of TKI due to suboptimal response/ treatment failure (more than 1 line of treatment solely due to toxicity will be included in the study). 2-Patient in accelerated or blast phase at presentation. 3-Patients with secondary CML (secondary to previous anti-cancer therapy).

Design outcomes

Primary

MeasureTime frame
Percentage of patients maintaining Treatment-Free Remission (TFR).Timepoint: 12 months and 24 months post-TKI discontinuation.—

Secondary

MeasureTime frame
Molecular Relapse-Free SurvivalTimepoint: From discontinuation up to 24 months.;Prognostic Factor AnalysisTimepoint: At 24 months;Impact of DMR DynamicsTimepoint: At 12 and 24 months.;Resolution of ToxicityTimepoint: Baseline, 12 months, and 24 months.—

Countries

India

Contacts

Public ContactDrNirmalya Roy Moulik

Tata Memorial Centre

roymoulik@gmail.com7045991385

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026