Treatment free remission with generic Imatinib
- Conditions
- Health Condition 1: null- CHRONIC MYELOID LEUKEMIA
- Registration Number
- CTRI/2018/08/015357
- Lead Sponsor
- PGIMER CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients diagnosed with CML-CP who are receiving treatment with Imatinib for at least 3 years of duration and are > 18 years old.
2.The patients must have attained the milestones of disease monitoring as per the recommended guidelines.
3.The patients must be compliant to the treatment with regular follow up and molecular monitoring. (As per data recorded in their respective files)
4.The patients must have molecular response of at least MR 4 (BCR-ABL transcript levels < 0.01), which is sustained for at least 3 years before the imatinib discontinuation is attempted.
5.Patients who are on generic forms of imatinib will be included in the study.
6.Before entering the study the patients should understand the investigational nature of this study, regular follow up as advised and should sign the consent form.
1.Patients diagnosed with advanced form of disease CML-AP (Accelerated Phase) and CML-BP (Blast Phase).
2.Patients who are incompliant to the treatment with frequent interruption of medication despite being in sustained molecular response.
3.Patients who are seropositive for HIV, HBsAg and HCV.
4.Patients who have other concomitant disease (connective tissue disorders, second malignancy etc.) will be excluded from the study.
5.Those who do not sign the consent form.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To study the outcome of treatment free remission (TFR) in patients with CML who are in sustained deep molecular response.Timepoint: 1.To study the outcome of treatment free remission (TFR) in patients with CML who are in sustained deep molecular response.
- Secondary Outcome Measures
Name Time Method 1.To identify the factors associated with duration of treatment free remission status. <br/ ><br>2.To assess the clinical outcome after the discontinuation of the generic forms of imatinib. <br/ ><br>3.To assess the response to re-challenge with imatinib in patients who had loss of major molecular response (MMR). <br/ ><br>Timepoint: JULY 2017 TO DECEMBER 2018