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

C

Command Hospital, India

Status

Unknown

Conditions

Treatment Free Remission
Chronic Myeloid Leukemia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03062436
AFMRC 4714/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

Sustained molecular remission
Experimental group
Description:
Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy
Treatment:
Diagnostic Test: Quantitative bcrabl recording every month for first 6 months
Other: Stopping the standard drug therpy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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