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

Command Hospital, India

Status: Unknown

Conditions: Treatment Free Remission; Chronic Myeloid Leukemia

Treatments: Other: Stopping the standard drug therpy; Diagnostic Test: Quantitative bcrabl recording every month for first 6 months

Study type: Interventional

Funder types: Other

Identifiers

NCT03062436

AFMRC 4714/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Sustained molecular remission

Experimental group

Description:

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

Treatment:

Diagnostic Test: Quantitative bcrabl recording every month for first 6 months

Other: Stopping the standard drug therpy