Chronic myeloid leukemia
Conditions
Interventions
Nilotinib is administered 400mg(2cap) bid ruled intake 1hr before or 2 hrs after a meal
Sponsors
Osaka CML-MRD Meeting
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Philadelphia positive CML patients with chronic phase 2)Imatinib resistant or Intolerant patients 3) age >= 15 years old 4) Performance Status (ECOG) 0-2 5) Keeping major organ function and filling following condition; -Neutrophil: >= 1,000 / cubic millimeter -Platelet: >= 50,000 / cubic millimeter -Hb: > = 8.0 g /dL -sCr: < = 3.0 times Upper Limit Normal of each establishment(ULN) -s-bilirubin: < = 3 times ULN -AST(GOT) / ALT(GOT):< = 5 times ULN -Lipase: < = 2 times ULN 6) Patient who can visit his study site routinely 7) Taking agreement by document from patient himself (in a case which patient is less than 20 years old, both patient and his/her stake holder) regarding participation for this clinical study
Exclusion criteria
Exclusion criteria: 1) accelerating phase(AP) patients with following one or more condition or suspected blast phase (BC) patients AP: -blast rate >= 15% in peripheral blood or bone marrow, and < 30% in both peripheral blood and bone marrow -blast + promyelocyte : >= 30% in peripheral blood or bone marrow -basophil rate: >= 20% in peripheral blood -platelet: continuous decline on treatment independently (<= 10,000 / cubic millimeter) BC: -blast: >= 30% in peripheral blood or bone marrow -No blast increase extramedullary except hepatosplenomegaly proven by biopsy 2) No drug history of Hydrea or IFN-alpha as CML treatment 3) Class 3, 4 in NYHA 4) Double invasive cancer within 5 years before beginning of Nilotinib 5) Uncontrollable disease complication 6) Diagnosed HIV 7) patients during pregnancy or possible in pregnancy 8) Patients during lactation or expecting pregnancytients 9) Patients with psychiatric disease or psychological symptom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Molecular response rate at 12 months treatment by Nilotinib 400mg bid | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Complete hematologic response (CHR) rate at 3,6,12,18,24 months treatment by Nilotinib 2) Cytogenetic response (CyR) rate at 3,6,12,18,24 months treatment by Nilotinib 3) Molecular response at 3,6,18,24 months treatment by Nilotinib 4) Progression Free survival at 24 months treatment by Nilotinib 5) Review of safety (category, grade and frequency of adverse events based on Nilotinib) 6) Correlation between term from diagnostic confirmation of CML to beginning Nilotinib treatment and Nilotinib efficacy (Cytogenetic response / Molecular genetic response) 7) Comparison of Nilotinib efficacy for Imatinib resistant patients with those for Imatinib intolerant patients at 12 or 24 months treatment by Nilotinib 8) Correlation between BCR/ABL poin-mutaion to molecular response | — |
Countries
Japan
Contacts
Public ContactItaru Mtsumura
Osaka University Graduate School of Medicine Department of Hematology/Oncology,
Outcome results
None listed