This trial is comparing the effectiveness of ponatinib (Iclusig) with imatinib (Gleevec) together with low-dose standard chemotherapy for the treatment of patients with acute lymphoblastic leukemia (ALL). The main outcome to be measured is minimal residual disease (low levels of cancer markers in the blood). This study will be conducted in California, South Carolina, and Texas, USA.
The details
Acute lymphoblastic leukemia (ALL) is a cancer of the bone marrow. It is often treated with drugs that target certain proteins on cancer cells. It is important to research different treatments for ALL to find the most effective drug.
The main outcome to be measured is the level of cancer marker in the blood and response to treatment.
Who are they looking for?
320 patients will be recruited for this study. To participate in the study, patients be newly diagnosed with ALL that is philadelphia chromosome positive (Ph+; a genetic abnormality).
Patients should not be taking any cancer medication or drugs which may affect the heart rhythm. Patients must not have any active infections that require antibiotics, should not have a bleeding disorder, recent surgery, uncontrolled lipids in the blood, or pancreatic dysfunction. Patients with any central nervous system conditions will be excluded.
How will it work
There will be two groups for this study. One group will receive ponatinib tablets once daily, with standard chemotherapy drugs in a low dose. Group two will receive imatinib tablets once daily with the same chemotherapy drugs. After 20 cycles, participants will remain on ponatinib or imatinib alone.
Patients will be followed up every 3 months up to 5 years. The outcomes measured will be response to treatment, side effects, and survival.
