Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
ACTREC, Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient should be currently enrolled in the Max Access Solution (MAS) program of the Max Foundation. (This program was previously known as the GIPAP (Global International Patient Access Program). Under this program, enrolled patients are already receiving imatinib from the Max Foundation.) 2.Chronic phase CML (CML-CP) 3.On imatinib for more than 10 years 4.No history of imatinib resistance 5.RQ-PCR IS value less than 0.0032% for a minimum of 12 months (confirmed at least twice)
Exclusion criteria
Exclusion criteria: 1.Patients with accelerated phase or blast crisis at any point of time in the past 2.Patients not willing to sign the informed consent form /personal data notice.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine the proportion of patients who will continue to remain in major molecular response (MMR) at 1 year (+/- 1 month) of discontinuation of imatinib.Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To determine the kinetics of RQ-PCR for BCR-ABL in patients under TFR 2.To determine the incidence of “imatinib withdrawal ?. (Imatinib withdrawal refers to a symptom complex which occurs due to sudden discontinuation of imatinib. The manifestations typically include bodyache, mild joint pains and occasionally low-grade fever). 3.In the event of TFR failure, to determine the proportion of patients who regain MMR after restarting imatinib. (TFR failure is defined below) Timepoint: 3 years | — |
Countries
India
Contacts
Public ContactDr Sachin Punatar
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre
Outcome results
None listed