Clinical trial · Interventional
To Study the Impact of Stopping Therapy in Patients of CML With Molecular Remission
Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In case there is evidence of disease recurrence on highly sensitive molecular assays, their drug therapy is restarted. The study aims to identify proportion of patients who can be kept off drug therapy in a state of sustained molecular remission.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Treatment Free Remission | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quantitative bcrabl recording every month for first 6 months | Diagnostic Test | — | UNRESOLVED |
| Stopping the standard drug therpy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sustained molecular remission
- description
- Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy
- interventionNames
- Other: Stopping the standard drug therpy
- Diagnostic Test: Quantitative bcrabl recording every month for first 6 months
Primary outcomes (1)
- measure
- Disease Recurrence
- timeFrame
- 12 months from cessation of the drug therapy
- description
- Re-appearance of bcr-abl transcripts by RQPCR at a level \>0.01%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients of CML on TKI (Imatinib) therapy for more than 5 years 2. Patients who have been in complete molecular response (MR 4.5 +) for at least three years Exclusion Criteria: 1. Patients who ever had blast crisis 2. Patients achieving molecular response with second generation TKI due to failure of Imatinib
References
Publications (0)
Data not yet available