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To stop the use of Imatinib in CML-CP patients

STOP IMATINIB MESYLATE IN PATIENTS OF CHRONIC MYELOID LEUKEMIA- CHRONIC PHASE(CML-CP)- A PILOT STUDY. - ISTIM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/07/020407
Enrollment
40
Registered
2019-07-29
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: - Health Condition 2: C921- Chronic myeloid leukemia, BCR/ABL-positive

Interventions

None listed

Sponsors

DR BRA IRCH AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a). Age >= 18 years b). CML-CP on imatinib mesylate c). Optimal response to imatinib d). Minimum duration of imatinib mesylate treatment of 3 years e) At least complete molecular remission MR4 f). Deep molecular remission duration should be at least one year g) Baseline data and documentation of treatment should be available for outside treated patients

Exclusion criteria

Exclusion criteria: a) Patients who had CML-accelerated phase/ blast crisis at diagnosis b) High Sokal score c). Not willing for the study d) Pregnancy e) Female patient not willing to use contraception f) Patients not willing for regular follow up

Design outcomes

Primary

MeasureTime frame
TO DETERMINE DURATION OF COMPLETE MOLECULAR RESPONSE IN SUBJECTS AFTER STOPPING IMATINIB MESYLATE THERAPYTimepoint: AT END OF 2 YEARS FROM ENROLMENT

Secondary

MeasureTime frame
IDENTIFICATION OF CLINICAL AND LABORATORY PREDICTORS OF PERSISTENCE COMPLETE MOLECULAR RESPONSE AFTER STOPPING IMATINIB MESYLATETimepoint: AT END OF 2 YEARS FROM ENROLMENT;TO EVALUATE QUALITY OF LIFE IN PATIENTS AFTER STOPPING IMATINIB MESYLATETimepoint: AT ENROLMENT IN THIS STUDY

Countries

India

Contacts

Public ContactDr Lalit Kumar

AIIMS

lalitaiims@yahoo.com911126593405

Outcome results

None listed

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