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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03062436

Enrollment

Registered

2017-02-23

Start date

2017-08-01

Completion date

2020-12-31

Last updated

2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia, Treatment Free Remission

Keywords

CML, treatment free remission

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.

Interventions

OTHERStopping the standard drug therpy

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

DIAGNOSTIC_TESTQuantitative 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

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

Design outcomes

Primary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026