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

NCT03062436 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-07-23

No results posted yet for this study

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.

Conditions

  • Chronic Myeloid Leukemia
  • Treatment Free Remission

Interventions

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

Sponsors & Collaborators

  • Command Hospital, India

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062436 on ClinicalTrials.gov