Health Condition 1: null- CHRONIC MYELOID LEUKEMIA
Conditions
Interventions
Intervention1: Discontinuation of Imatinib: To asses treatment free remission
Control Intervention1: NIL: NIL
Sponsors
PGIMER CHANDIGARH
Eligibility
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. To identify the factors associated with duration of treatment free remission status. 2. To assess the clinical outcome after the discontinuation of the generic forms of imatinib. 3. To assess the response to re-challenge with imatinib in patients who had loss of major molecular response (MMR). Timepoint: JULY 2017 TO DECEMBER 2018 | — |
Countries
India
Contacts
Public ContactDr Deepak Goni
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH. CHANDIGARH
Outcome results
None listed