To Study the Impact of Stopping Therapy in Patients of CML With Molecular Remission

Study Overview
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Brief Summary
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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.

Detailed Description
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While a large number of studies which have stopped TKI therapy in similar patients exist in Europe and USA, no such study has been done on Indian or other south Asian population. Almost all studies done previously have noted that in relapsed patients, who show disease recurrence on stopping their TKI therapy, their remission state is regained once the TKI therapy is restarted.

Official Title
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Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission

Conditions
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Chronic Myeloid Leukemia, Treatment Free Remission

Intervention / Treatment
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* Other: Stopping the standard drug therpy
* Diagnostic Test: Quantitative bcrabl recording every month for first 6 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of CML on TKI (Imatinib) therapy for more than 5 years Patients who have been in complete molecular response (MR 4.5 +) for at least three years Exclusion Criteria: Patients who ever had blast crisis Patients achieving molecular response with second generation TKI due to failure of Imatinib

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sustained molecular remission<br>Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy | Other: Stopping the standard drug therpy<br>* Stopping the standard drug therapy of CML patients and monitoring their treatment free remission status<br>Diagnostic Test: Quantitative bcrabl recording every month for first 6 months<br>* Monthly recording of quantitative bcrabl by RQPCR on patients peripheral blood derived RNA. RQPCR will have minimum sensitivity of log4.5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Recurrence | Re-appearance of bcr-abl transcripts by RQPCR at a level >0.01% | 12 months from cessation of the drug therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, treatment free remission