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

NCT ID: NCT03062436

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-12-31

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.

Conditions

Chronic Myeloid Leukemia; Treatment Free Remission

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sustained molecular remission

Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy

Group Type: EXPERIMENTAL

Stopping the standard drug therpy

Intervention Type: OTHER

Stopping the standard drug therapy of CML patients and monitoring their treatment free remission status

Quantitative bcrabl recording every month for first 6 months

Intervention Type: DIAGNOSTIC_TEST

Monthly recording of quantitative bcrabl by RQPCR on patients peripheral blood derived RNA. RQPCR will have minimum sensitivity of log4.5

Interventions

Stopping the standard drug therpy

Stopping the standard drug therapy of CML patients and monitoring their treatment free remission status

Intervention Type: OTHER

Quantitative bcrabl recording every month for first 6 months

Monthly recording of quantitative bcrabl by RQPCR on patients peripheral blood derived RNA. RQPCR will have minimum sensitivity of log4.5

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Command Hospital, India

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sanjeevan Sharma

Clinical Hematologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Command Hospital

Pune, Maharashtra, India

Countries

India

Other Identifiers

AFMRC 4714/2016

Identifier Type: -

Identifier Source: org_study_id