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A Study of Treatment Reduction and Discontinuation in Children with Well-Controlled Chronic Myeloid Leukemia

A Phase II, Single-Center, Single-Arm Study of Tyrosine Kinase Inhibitor (TKI) Deescalation Followed by Treatment-Free Remission in Pediatric Chronic Myeloid Leukemia in Chronic Phase (CML-CP) with Sustained Major Molecular Response (MMR), including Patients with Prior Failure of First TFR Attempt - Peds-DTFR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109516
Enrollment
60
Registered
2026-04-28
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: STOPPING TYROSINE KINASE INHIBITORS: Nil Intervention2: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

TMHPAREL MUMBAI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants must meet the following to enroll Age Diagnosis of CML less than 15 years Disease Status Chronic phase CML with typical BCR ABL1 transcripts e13a2 e14a2 Performance Adequate organ function and performance status more than or equal to 60 percent Patient Groups Group 1 MMR Group Stable MMR MR3 less than 0 point 1 percent for at least 5 years Group 2 Failed TFR 1 Failed a prior TFR attempt but has been in stable DMR for at least 2 years after restart

Exclusion criteria

Exclusion criteria: Exclusion Criteria Prior accelerated or blast phase. History of TKI resistance/failure or kinase domain mutations. Atypical transcripts not quantifiable on RQ-PCR. Pregnancy or breastfeeding. History of poor adherence.

Design outcomes

Primary

MeasureTime frame
LOSS OF MAJOR MOLECULAR RESPONSE Timepoint: 12 MONTHS—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr NIRMALYA ROY MOULIK

TATA MEMORIAL CANCER HOSPITAL ,PAREL MUMBAI

nirmalyaroymoulik@gmail.com917045991385

Outcome results

None listed

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