Nilotinib Combined by Chemotherapy for Myeloid Blastic Phase of Chronic Myeloid Leukemia or Bcr-abl Positive Acute Myeloid Leukemia
1. IMATINIB COMBINED WITH CHEMOTHERAPY FOR PHYLADELPHIA POSITIVE ACUTE LYMPHOBLASTIC
LYMPHOMA (PH+ ALL) The trials combining imatinib with high-dose chemotherapy were
successfully resulting in high response rate and longer survival and a role for
bridging therapy to allogeneic hematopoietic stem cell transplantation (alloHSCT) by
means of concurrent or alternating regimen in patients with Philadelphia-positive (Ph+)
acute lymphoblastic leukemia (ALL).(24-29) Current combination therapy of imatinib and
chemotherapy became standard therapy of Ph+ ALL and new 2nd generation TKIs are
investigating. These experiences may be translated into the treatment of CML BP.
2. HIGH-DOSE DAUNORUBICIN IN ACUTE MYELOID LEUKEMIA (AML) INDUCTION CHEMOTHERAPY Two
recently published papers of randomized trials comparing standard dose daunorubicin (45
mg/m2 for 3 days) and high dose daunorubicin (90 mg/m2 for 3 days) demonstrated
improved CR rate and survival with high dose daunorubicin in younger (60 years or
younger) and older (over 60 years) patients, respectively.(30, 31) Therefore high-dose
daunorubicin can be applied safely and effectively to the treatment of CML BP.
3. NILOTINIB COMBINED WITH CHEMOTHERAPY FOR PHYLADELPHIA POSITIVE CML MYELOID BLASTIC
PHASE (MBP) OR PHYLADELPHIA POSITIVE AML We will try 2nd generation TKI, nilotinib and
high-dose daunorubicin induction chemotherapy combination to find out the combination
therapy can improve response rate and survival in patients with CML MBP.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate
Primary purpose of this study is to define the efficacy of combined chemotherapy and nilotinib in chronic myeloid leukemia (CML) myeloid blastic phase (MBP) and bcr-abl positive acute myeloid leukemia (AML). The efficacy will be evaluated by complete remission (CR) rate.
Within 8 weeks after induction therapy
Hawk Kim, M.D., Ph.D.
Ulsan University Hospital, University of Ulsan College of Medicine
Korea: Food and Drug Administration