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

Chronic Myeloid Leukemia Clinical Trial

Official title:

Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03062436
• Other study ID #: AFMRC 4714/2016
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Treatment Free Remission

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