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

NCT03062436 | Unknown

• 1 other identifier: AFMRC 4714/2016
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia; Treatment Free Remission

Keywords

CML, treatment free remission

Outcome Measures

Primary Outcomes (1)

• Disease Recurrence

  Re-appearance of bcr-abl transcripts by RQPCR at a level \>0.01%

  12 months from cessation of the drug therapy

Study Arms (1)

Sustained molecular remission

EXPERIMENTAL

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

Other: Stopping the standard drug therpy; Diagnostic Test: Quantitative bcrabl recording every month for first 6 months

Interventions

Stopping the standard drug therpy OTHER

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

Sustained molecular remission

Quantitative bcrabl recording every month for first 6 months DIAGNOSTIC_TEST

Monthly recording of quantitative bcrabl by RQPCR on patients peripheral blood derived RNA. RQPCR will have minimum sensitivity of log4.5

Sustained molecular remission

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Command Hospital, India: lead

Study Sites (1)

Command Hospital

Pune, Maharashtra, 411040, India

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Hematologist

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 1, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)