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Stopping imatinib in selected pediatric patients with chronic myeloid leukemia

Cessation of imatinib in Pediatric, adolescent and young adults chronic myeloid leukemia (CIPC) : A prospective observational study - CIPC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/032690
Enrollment
70
Registered
2021-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

None listed

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: It will be a prospective observational study which will include patients diagnosed with CML in chronic phase with age less than or equal to 30 years at the time of diagnosis. Patients who are on imatinib for more than 3 years, and are in MMR for more than two years, imatinib will be stopped.

Exclusion criteria

Exclusion criteria: Patient age > 30 years Patient diagnosed in CML AP/BP at baseline Patient on imatinib less than 3 years Patient in MMR for less than two years Refusal of consent

Design outcomes

Primary

MeasureTime frame
To determine proportion of patients who are in molecular remission after stopping imatinib at the end of 6 months and 12 months.Timepoint: At 6 and 12 months

Secondary

MeasureTime frame
Secondary objective: 1. Identification of clinical and biological factors affecting the persistence of MMR after stopping imatinib. 2. Evaluation of quality of life (QoL) in patients after stopping imatinib and comparison with when they were on imatinib. 3. Evaluation of medico-economic impact of stopping imatinib. Timepoint: At baseline, at 6 month and 12 month

Countries

India

Contacts

Public ContactDEEPAM PUSHPAM

AIIMS

deepampushpam@gmail.com9650629370

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026