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

Sponsor

Command Hospital, India (Other)

Overall Status

Unknown status

CT.gov ID

NCT03062436

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia Treatment Free Remission	Other: Stopping the standard drug therpy Diagnostic Test: Quantitative bcrabl recording every month for first 6 months	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission

Actual Study Start Date :

Aug 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sustained molecular remission Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy	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

Arm

Intervention/Treatment

Experimental: Sustained molecular remission

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

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

Outcome Measures

Primary Outcome Measures

Disease Recurrence [12 months from cessation of the drug therapy]
Re-appearance of bcr-abl transcripts by RQPCR at a level >0.01%

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients of CML on TKI (Imatinib) therapy for more than 5 years
Patients who have been in complete molecular response (MR 4.5 +) for at least three years

Exclusion Criteria:

Patients who ever had blast crisis
Patients achieving molecular response with second generation TKI due to failure of Imatinib

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Command Hospital	Pune	Maharashtra	India	411040

Sponsors and Collaborators

Command Hospital, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanjeevan Sharma, Clinical Hematologist, Command Hospital, India

ClinicalTrials.gov Identifier:

NCT03062436

Other Study ID Numbers:

AFMRC 4714/2016

First Posted:

Feb 23, 2017

Last Update Posted:

Jul 23, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sanjeevan Sharma, Clinical Hematologist, Command Hospital, India

CML, treatment free remission

Additional relevant MeSH terms:

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Tin Fluorides

Study Results

No Results Posted as of Jul 23, 2019