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Tyrosine Kinase Inhibitor
Treatment-free Remission After Nilotinib for Chronic Myeloid Leukemia (ENESTop Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status of 0, 1, or 2
Patient with diagnosis of BCR-ABL positive CML CP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessation
Awards & highlights
ENESTop Trial Summary
This trial is testing whether it's safe to stop taking the drug nilotinib in patients with chronic myeloid leukemia who have been on it for at least 2 years and have only a small amount of leukemia cells remaining.
Who is the study for?
Adults diagnosed with chronic myeloid leukemia (CML) who have been treated first with imatinib for over 4 weeks, then switched to nilotinib for at least 2 years, totaling a minimum of 3 years of treatment. They must show very low levels of leukemia cells after nilotinib treatment and meet specific health criteria like normal organ function and blood counts.Check my eligibility
What is being tested?
The study is testing the safety of stopping the drug nilotinib in CML patients who have responded well to it. It aims to see if these patients can maintain their health without continuing the medication after achieving a significant reduction in leukemia cells.See study design
What are the potential side effects?
While not specified here, common side effects from taking nilotinib may include headache, fatigue, nausea, rash, muscle pain, itching or other skin problems. Stopping treatment could potentially lead to an increase in white blood cell count as the body adjusts.
ENESTop Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with chronic myeloid leukemia in the chronic phase.
Select...
I've been treated with specific cancer drugs for over 3 years since my diagnosis.
Select...
I have been treated with nilotinib for at least 2 years.
Select...
My cancer has responded very well to nilotinib treatment.
ENESTop Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks
Secondary outcome measures
Change in BCR-ABL (Oncoprotein Product of BCR-ABL Fusion Gene) Transcripts After Re-start of Nilotinib Therapy
Overall Survival (OS)
Percentage of Patients With Stable MMR in Nilotinib Re-initiation Phase
+5 moreSide effects data
From 2019 Phase 3 trial • 846 Patients • NCT0047149745%
Rash
38%
Headache
32%
Nausea
31%
Alanine aminotransferase increased
24%
Diarrhoea
24%
Nasopharyngitis
24%
Upper respiratory tract infection
23%
Arthralgia
23%
Back pain
22%
Vomiting
22%
Abdominal pain upper
22%
Cough
21%
Alopecia
21%
Thrombocytopenia
20%
Hypertension
20%
Fatigue
20%
Hypophosphataemia
20%
Myalgia
20%
Pruritus
19%
Constipation
19%
Hyperbilirubinaemia
19%
Pain in extremity
18%
Influenza
18%
Pyrexia
17%
Abdominal pain
16%
Oedema peripheral
16%
Anaemia
16%
Aspartate aminotransferase increased
15%
Blood bilirubin increased
14%
Hypercholesterolaemia
14%
Dry skin
14%
Muscle spasms
14%
Lipase increased
14%
Musculoskeletal pain
13%
Dyspepsia
13%
Insomnia
12%
Dizziness
11%
Neutropenia
11%
Dyspnoea
10%
Asthenia
10%
Oropharyngeal pain
10%
Sinusitis
10%
Urinary tract infection
10%
Bone pain
10%
Hyperglycaemia
9%
Non-cardiac chest pain
8%
Decreased appetite
8%
Leukopenia
8%
Amylase increased
8%
Weight increased
8%
Dry eye
8%
Gastroenteritis
8%
Anxiety
7%
Haemorrhoids
7%
Bronchitis
7%
Palpitations
6%
Blood alkaline phosphatase increased
6%
Gastrooesophageal reflux disease
6%
Pharyngitis
6%
Conjunctivitis
6%
Folliculitis
6%
Hyperhidrosis
6%
Erythema
6%
Night sweats
6%
Depression
6%
Gastritis
5%
Flatulence
5%
Chills
5%
Blood cholesterol increased
5%
Influenza like illness
5%
Blood phosphorus decreased
5%
Haemoglobin decreased
5%
Procedural pain
5%
Hyperlipidaemia
5%
Abdominal distension
5%
Hyperuricaemia
5%
Vertigo
5%
Weight decreased
4%
Coronary artery disease
4%
Toothache
4%
Blood creatinine increased
4%
Hypoaesthesia
4%
Angina pectoris
4%
Neck pain
4%
Hypokalaemia
4%
Eczema
4%
Paraesthesia
3%
Face oedema
3%
Herpes zoster
2%
Myocardial infarction
2%
Pneumonia
2%
Transient ischaemic attack
2%
Conjunctival haemorrhage
2%
Acute myocardial infarction
2%
Eyelid oedema
2%
Peripheral arterial occlusive disease
1%
Intestinal obstruction
1%
Angina unstable
1%
Pilonidal cyst
1%
Inguinal hernia
1%
Death
1%
Cellulitis
1%
Migraine
1%
Cerebral haemorrhage
1%
Periorbital oedema
1%
Neuropathy peripheral
1%
Azotaemia
1%
Peripheral artery stenosis
1%
Coronary artery stenosis
1%
Carotid artery stenosis
1%
Renal failure
1%
Benign prostatic hyperplasia
1%
Febrile neutropenia
1%
Gastrointestinal haemorrhage
1%
Myocardial ischaemia
1%
Pancreatitis
1%
Atrial fibrillation
1%
Pancreatitis acute
1%
Hepatic function abnormal
1%
Sepsis
1%
Femur fracture
1%
Road traffic accident
1%
Cerebrovascular accident
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nilotinib 400 mg BID
Imatinib 400 mg QD
All Patients
Nilotinib 300 mg BID
ENESTop Trial Design
1Treatment groups
Experimental Treatment
Group I: NilotinibExperimental Treatment1 Intervention
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nilotinib
2009
Completed Phase 4
~4140
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,190 Total Patients Enrolled
151 Trials studying Leukemia
23,669 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I have been diagnosed with chronic myeloid leukemia in the chronic phase.I've been treated with specific cancer drugs for over 3 years since my diagnosis.I have been treated with nilotinib for at least 2 years.I switched from imatinib to nilotinib with a MR4.5 status.My cancer has a known unusual genetic change.I have had a bone marrow or stem cell transplant before.My CML has mutations known to resist treatment.I've had medication doses lowered due to low white blood cell or platelet counts in the last 6 months.I have tried to stop taking imatinib or nilotinib permanently.I am 18 years old or older.My cancer has responded very well to nilotinib treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Nilotinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks come with administering nilotinib to individuals?
"Due to the Phase 2 status of this trial, we have assigned nilotinib a safety score of 2. This is based on some evidence showing its relative safety but lack of supporting efficacy data."
Answered by AI
Is there capacity to enroll more participants in this experiment?
"This clinical trial has already stopped taking applications; it was initially published on December 20, 2012 and last updated March 17th 2022. If you are still looking for studies to enroll in, 1454 trials concerning leukemia are currently recruiting participants and 35 more related to nilotinib have open enrollment at the moment."
Answered by AI
Is there a body of research surrounding nilotinib's efficacy?
"Nilotinib is the target of 35 medical studies, 6 at Phase 3. It can be found in Fukuoka city and 1548 other research sites across the world."
Answered by AI
Is this a pioneering endeavor in its field?
"Nilotinib has been analyzed since 2008, when Novartis Pharmaceuticals first began researching the drug. The initial trial involved 34 participants and after that nilotinib was granted Phase 4 authorization. Nowadays there are 35 active trials for this substance in 42 different countries spread over 566 cities."
Answered by AI
At what sites is this scientific experiment taking place?
"9 different medical sites are authorised to operate this trial, among which Compass Oncology in Hamilton, USC Kenneth Norris Comprehensive Cancer Center USC in Toronto and St. Agnes Hospital SC in Quebec stand out. Additional locations exist as well."
Answered by AI
What is the current enrolment count for this trial?
"This medical trial is no longer accepting patients. It originally appeared online in December 2012 and was last updated on March 17th, 2022. If you're looking for alternative trials, at present there are 1454 studies enrolling leukemia sufferers and 35 research programmes that require participants undergoing nilotinib treatment."
Answered by AI
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