Clinical trial NCT02272777: A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
Official title: An Open-label Multi-center Study of Imatinib and Nilotinib in CAMN107ECN02 On-treatment Patients With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase After the End of CAMN107ECN02 Core Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia
Keywords: Nilotinib
AMN107
Tasigna
Imatinib
STI571
Gleevec/Glivec
BCR-ABL Positive
Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
Chronic myelogenous leukemia
Chronic myeloid leukemia
Chronic myelocytic leukemia
Acute Lymphoblastic Leukemia (ALL) Philadelphia chromosome positive
Acute Lymphoid Leukemia
suboptimal molecular response
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-10-23
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension study patient continued treatment of the drug (imatinib or nilotinib) which they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As long as EC approval and agreement from investigators were obtained, the selected sites for CAMN107ECN02 were applied in this extension study.

Detailed description: Up to 230 patients who benefited from the core study treatment (imatinib or nilotinib), at Investigator's discretion, were enrolled into this extension study. The patients continued receiving the open-label drugs that they were taken by the end of core study. Treatment arms in the core study were retained. No crossover between the arms was allowed.

The extension study started from the first patient last dose date in the core study and ends at the time of nilotinib was commercially available in China as a first line treatment. Eligibility evaluations were given for each patient before the enrollment. Follow-up visits at a frequency of 6 months were required to report AE, SAE and pregnancy only. No efficacy data were collected in the extension study since full efficacy had already been analyzed in the core study.

Eligibility criteria: Key Inclusion Criteria

1. Patient is currently on treatment in the core study CAMN107ECN02
2. Patient who continues to derive benefit more than risk from the study treatment he/she takes in CAMN107ECN02, in the opinion of the investigator at the end of the study
3. Written informed consent must be obtained prior to enrolling in the extension study

Key Exclusion Criteria:

1. Progression to CML-AP or BC
2. Patient whose treatment assigned in CAMN107ECN02 is not appropriate any longer, per investigator's assessment.
3. History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
4. Women who are (a) pregnant and(b) women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and at least 14 days after last dose of study medication. Highly effective contraception methods include:

   * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
   * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
   * Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
   * Combination of any two of the following (a+b or a+c, or b+c):

     1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
     2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
     3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Fuzhou
country: China
facility: Novartis Investigative Site
city: Jinan
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: