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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Clinicaltrials.gov identifier NCT03942094

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted February 26, 2020

Study Description

Brief summary:

This is a phase IIIb, multi-centre, single-arm, open-label, prospective study investigating the efficacy and safety of nilotinib as the first-line treatment for the adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) in China. Nilotinib 300 mg BID will be provided in this study. The assessment for the primary efficacy endpoint will be performed at 18 months and the rate of patients obtaining MR4.5 will be measured at this time point. Secondary endpoints include the complete hematologic response(CHR) and the rates of major molecular reactions (MMR) by 3, 6, 9,12,18 and 24 months; event free survival (EFS); overall survival (OS).

  • Condition or Disease:Chronic Myeloid Leukemia, Chronic Phase
    Nilotinib
  • Intervention/Treatment: Drug: Nilotinib
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia: a Prospective Study
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: December 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Nilotinib
Drug: Nilotinib
Nilotinib (Tasigna ®), capsules of 150 mg Nilotinib 2 capsules of 150 mg, orally, twice daily
Outcome Measures
  • Primary Outcome Measures: 1. Molecular response (MR) 4.5 at 18 months of nilotinib 300 mg twice a day [ Time Frame: 18 months ]
  • Secondary Outcome Measures: 1. Molecular Response 4.5 at 3, 6, 9, 12, 24 months of nilotinib [ Time Frame: 24 months ]
  • 2. Major Molecular Response at 3, 6, 9, 12, 24 months of nilotinib [ Time Frame: 24 months ]
  • 3. Rate of CCyR (complete cytogenetic responses: bone marrow Philadelphie positive at 0 % on at least 20 metaphases) at 3, 6, 9, 12, 24 months of nilotinib. [ Time Frame: 24 months ]
  • 4. Event-free survival [ Time Frame: 24 months ]
    Survival since randomization without any event defined as loss of CHR, loss of PCyR or CCyR, death from any cause, progression towards accelerated phase or blast crisis.
  • 5. Overall survival [ Time Frame: 24 months ]
    Survival without death from any cause
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Male and female patients

- Newly diagnosed CP-CML within 6 months prior to study entry, positive Philadelphia
chromosome or positive BCR-ABL (M-bcr transcript)

- Age ≥ 18 years old (no upper age limit given)

- CML-CP defined by primordial cells in peripheral blood or bone marrow <20%, basophils in peripheral blood <20%, platelets ≥100 x 109/L(≥100,000/mm3), except for hepatosplenomegaly - Patient for whom treatment with Imatinib within 2 weeks is expected No other CML treatment except for hydroxyurea and/or anagrelide and/or IFN ECOG score 0 to 2 - Organ function defined by total serum bilirubin levels < 1.5 × the upper limit of the normal range (ULN), SGOT and SGPT < 2.5 UNL, creatinine < 1.5 × ULN, amylase and lipase ≤ 1.5 × ULN and alkaline phosphatase ≤ 2.5 × ULN not directly related to the CML - Laboratory values defined by potassium ≥ LLN, magnesium ≥ LLN, phosphate ≥ LLN, total calcium (correction for serum albumin) ≥ LLN - No planned allogeneic stem cell transplantation - Signed informed consent Exclusion Criteria: - Patients confirmed to have a T315I mutation - TKIs are not allowed to be treated prior to entering the study, unless the patient has an emergency pending the start of the study, and any dose of commercial imatinib may be used to the patient, but no more than 2 weeks - Treatment with IFN for more than 3 mouths - Impaired cardiac function including any of the following: 1. Complete left bundle branch block 2. Right bundle branch block plus left anterior hemiblock,bifascicular block 3. Use of a ventricular-paced pacemaker 4. Congenital long QT syndrome 5. Clinically significant ventricular or atrial tachyarrhythmias 6. Clinically significant resting bradycardia (450 msec on screening ECG.If QTcF >450 msec and electrolytes are not within
normal ranges before nilotinib dosing, electrolytes should be corrected and then
the patient rescreened for QTcF criterion

8. Myocardial infarction within 12 months prior to starting nilotinib

9. Other clinical significant heart disease (e.g. unstable angina,congestive heart
failure,uncontrolled hypertension)

- Patients who are confirmed CNS infiltration by cytopathology

- Concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or
uncontrolled infections)

- Congenital or acquired bleeding tendency

- Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or
who have not recovered from side effects of such therapy

- Received other study medications within 30 days (defined as drugs that cannot be used
based on approved indications)

- Patients unwilling or unable to comply with the protocol

- Patients with a history of another primary malignancy that is currently clinically
significant or currently requires active intervention

- Concomitant medications known to be strong inducers or inhibitors of the CYP450
Isoenzyme CYP3A4 (for example, erythromycin, ketoconazole, itraconazole, voriconazole,
clarithromycin, telithromycin, ritonavir, and midazolam)

- Impaired gastrointestinal function or disease that may alter the absorption of study
drug (e.g.ulcerative disease,uncontrolled nausea,vomiting and diarrhea,malabsorption
syndrome,small bowel resection or gastric by-pass surgery)

- History of acute pancreatitis within 12 months or chronic pancreatitis

- History of acute or chronic diseases of Liver, pancreas or kidney

- Concomitant medications with potential QT prolongation

- Patients who are pregnant or breast feeding or women of reproductive potential not
employing an effective method of birth control.Women of childbearing potential must
have a negative serum pregnancy test within 14 days prior to administration of
nilotinib.Post menopausal women must be amenorrheic for at least 12 months in order to
be considered of non-childbearing potential.Female patients must agree to employ an
effective barrier method of birth control throughout the study and for up to 3 months
following discontinuation of study drug

Contacts and Locations
Contacts
Locations

China, Guangdong
Shenzhen Second People's Hospital
Shenzhen

Sponsors and Collaborators

Shenzhen Second People's Hospital

More Information
  • Responsible Party: Shenzhen Second People's Hospital
  • ClinicalTrials.gov Identifier: NCT03942094 History of Changes
  • Other Study ID Numbers: Nilotinib20190426
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: February 26, 2020
  • Last Verified: November 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Shenzhen Second People's Hospital: Nilotinib
  • Additional relevant MeSH terms: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Leukemia
    Leukemia, Myeloid