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

Not Applicable

• Conditions: Treatment Free Remission; Chronic Myeloid Leukemia
• Interventions: Other: Stopping the standard drug therpy; Diagnostic Test: Quantitative bcrabl recording every month for first 6 months

• Registration Number: NCT03062436
• Lead Sponsor: Command Hospital, India

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-23
• Study Start: 2017-08-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23
• Primary Completion: 2019-12-31
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sustained molecular remission	Quantitative bcrabl recording every month for first 6 months	Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy
Sustained molecular remission	Stopping the standard drug therpy	Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy

Primary Outcome Measures

Name	Time	Method
Disease Recurrence	12 months from cessation of the drug therapy	Re-appearance of bcr-abl transcripts by RQPCR at a level \>0.01%

Trial Locations

Locations (1)

Command Hospital; 🇮🇳 Pune, Maharashtra, India