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

Phase 2

Withdrawn

Conditions: cancer of the blood
CML
10024324

Registration Number: NL-OMON38513

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

Male or female patients *18 years of age
ECOG performance status of 0-2
Patient with diagnosis of BCR-ABL positive CML
Patient has received minimum of 3 years of tyrosine kinase inhibitor treatment (first with imantinib and then switched to nilotinib) since initial diagnosis
Minimum of 2 calendar years of nilotinib treatment before study entry
Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening.
Adequate end organ function as defined by:
* Direct bilirubin * 1.5 x ULN
* SGOT(AST) and SGPT(ALT) * 3 x ULN
Serum lipase * 2 x ULN i.e. equivalent to * Grade 2 NCI-CTCAE v.4.03
* Alkaline phosphatase * 2.5 x ULN
* Serum creatinine < 1.5 x ULN
Patients must have the following electrolyte values above LLN limits or corrected to be within normal limits with supplements prior to
first dose of study medication:
* Potassium
* Magnesium
* Total calcium (corrected for serum albumin)
Patients must have normal marrow function as defined:
* Absolute Neutrophil Count (ANC) * 1.5 x 109/L
* Hemoglobin * 9.0 g/dL
* Platelets * 100 x 109/L

Exclusion Criteria

Prior AP, BC or allo-transplant
Patient has documented MR4.5 at the time when switched from imatinib to nilotinib
Patients with known atypical transcript
Mutation(s) (T351I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform
mutation testing at study entry if it was not done in the past)
Dose reductions due to neutropenia or thrombocytopenia in the past 6 months
Patient ever attempted to permanently discontinue imatinib or nilotinib treatment
Known impaired cardiac function
History of acute pancreatitis
Known presence of a significant congenital or acquired bleeding disorder unrelated to
cancer
History of other active malignancy within 5 years prior to study entry
Treatment with other investigational agents (defined as not used in accordance with the
approved indication) within 4 weeks of Day 1
Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and
the treatment cannot be either discontinued or switched to a different medication prior to
study entry.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the percentage of patients who are in MMR<br /><br>(BCR-ABL * 0.1% IS (MR3)) at 48 weeks after starting the Treatment-Free<br /><br>Remission (TFR) phase (patients who required re-initiation of treatment will be<br /><br>considered as non-responders)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the proportion of patients in TFR within 24, 36, and 48 monhs after<br /><br>nilotinib cessation.<br /><br>To estimate progression free survival after nilotinib cessation<br /><br>To estimate treatment free survival. </p><br>