臨床研究等提出・公開システム

A phase II, single arm, open label study of treatment-free remission in Chronic Myeloid Leukemia (CML) chronic phase (CP) patients after achieving sustained MR4.5 on nilotinib (CAMN107A2408)

Nilotinib treatment cessation study (CAMN107A2408)

Yamauchi Kyosuke

Novartis Pharma K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku2@novartis.com

Yamauchi Kyosuke

Novartis Pharma K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

completed

May. 23, 2013

Interventional

Single armx, Open label, multi-center trial

treatment purpose

2

Main Includion criteria
1) ECOG Performance Status of 0, 1, or 2
2) Patient with diagnosis of BCR-ABL positive CML CP
3) Patient has received a minimum of 3 years of tyrosine kinase inhibitor
treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis
4) Patient has at least 2 years of nilotinib treatment prior to study entry
5) Patient has achieved MR4.5 during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
6) Adequate bone marrow and organ function meeting laboratory criteria

Main Exclusion criteria
1) Prior AP, BC or allo-transplant
2) Patient has documented MR4.5 at the time when switched from imatinib to nilotinib
3) Patients with known atypical transcript.
4) CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if testing was done in the past
5) Severe and/or uncontrolled concurrent medical disease
6) History of other active malignancy within 5 years prior to study entry
7) Pregnant or nursing (lactating) women

Both

Chronic Myeloid Leukemia

All patients will be treated with 300 mg BID nilotinib or 400 mg BID nilotinib

efficacy
To evaluate the proportion of patients in Treatment-free remission (TFR) within 12 months following nilotinib cessation

efficacy
To evaluate the proportion of patients in TFR, PFS, TFS, OS, To characterize the kinetics of BCRABL transcript after re-start of nilotinib therapy

Mar. 25, 2013