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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03062436
Other study ID # AFMRC 4714/2016
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date December 2020

Study information

Verified date July 2019
Source Command Hospital, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 27
Est. completion date December 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
India Command Hospital Pune Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Command Hospital, India

Country where clinical trial is conducted

India, 

Outcome

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