NCT03062436

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

Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Command Hospital, India · Other Government
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Stopping the standard drug therpy	Stopping the standard drug therapy of CML patients and monitoring their treatment free remission status
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-12-31
• Completion: 2020-12-01
• First posted: 2017-02-23
• Last updated: 2019-07-23

Locations

1 site across 1 country: India