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Tyrosine Kinase Inhibitor

Nilotinib for Acute Lymphoblastic Leukemia

Phase 4
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up clinical benefit data were first collected 3 years after study initiation and are reported at baseline, weeks 24, 48, 72, 96, 144, 192, 240, 288, 336, 384, 432, 480, and 528.
Awards & highlights

Study Summary

This trial will allow people who are currently benefiting from nilotinib treatment to continue using the drug.

Eligible Conditions
  • Melanoma
  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~clinical benefit data were first collected 3 years after study initiation and are reported at baseline, weeks 24, 48, 72, 96, 144, 192, 240, 288, 336, 384, 432, 480, and 528.
This trial's timeline: 3 weeks for screening, Varies for treatment, and clinical benefit data were first collected 3 years after study initiation and are reported at baseline, weeks 24, 48, 72, 96, 144, 192, 240, 288, 336, 384, 432, 480, and 528. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events and Serious Adverse Events
Secondary outcome measures
Number of Participants With Clinical Benefit From Nilotinib

Side effects data

From 2014 Phase 3 trial • 267 Patients • NCT01275196
28%
Thrombocytopenia
27%
Leukopenia
23%
Platelet count decreased
22%
Lipase increased
21%
White blood cell count decreased
19%
Nasopharyngitis
19%
Eyelid oedema
14%
Anaemia
14%
Neutropenia
14%
Diarrhoea
13%
Hypophosphataemia
13%
Rash
12%
Alanine aminotransferase increased
12%
Neutrophil count decreased
11%
Haemoglobin decreased
11%
Pyrexia
11%
Vomiting
11%
Nausea
10%
Upper respiratory tract infection
10%
Hypokalaemia
9%
Blood creatine phosphokinase increased
8%
Hypertriglyceridaemia
8%
Blood phosphorus decreased
8%
Face oedema
7%
Aspartate aminotransferase increased
7%
Arthralgia
7%
Cough
6%
Myalgia
6%
Blood bilirubin increased
6%
Dizziness
5%
Influenza
4%
Hyperglycaemia
3%
Headache
3%
Hyperbilirubinaemia
2%
Abdominal pain upper
2%
Bilirubin conjugated increased
2%
Low density lipoprotein increased
2%
Apolipoprotein B increased
2%
Gamma-glutamyltransferase increased
2%
Hypercholesterolaemia
1%
Ovarian rupture
1%
Oesophageal squamous cell carcinoma
1%
Thrombocytosis
1%
Anal abscess
1%
Ankle fracture
1%
Blast cell count increased
1%
Intervertebral disc protrusion
1%
Cervix carcinoma stage 0
1%
Non-Hodgkin's lymphoma recurrent
1%
Cerebral haemorrhage
1%
Hydrothorax
1%
Thrombocytopenic purpura
1%
Bone marrow failure
1%
Granulocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imatinib 400 mg qd
Nilotinib 300 mg Bid

Trial Design

1Treatment groups
Experimental Treatment
Group I: NilotinibExperimental Treatment1 Intervention
Patients who were on nilotinib treatment in a Novartis-sponsored study (parent study) and were benefiting from nilotinib treatment met the criteria for enrolment into the CAMN107A2409 study and to receive continued nilotinib treatment. The starting dose of nilotinib in the CAMN107A2409 study should have been the same as the last dose administered in the parent study. After the starting dose, the dose of nilotinib was based on the investigator's judgement. The dose of nilotinib should have been ≤ 800 mg/day for adult patients, 230mg/m2 body surface area (BSA) and ≤ 800 mg/day for pediatric patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nilotinib
2005
Completed Phase 4
~2670

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,648 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental trial represent a pioneering effort?

"AMN107 has been studied extensively since 2008, when Novartis Pharmaceuticals completed the initial trial. Following that study of 34 patients, AMN107 received its Phase 4 drug approval and is now being examined in 35 different trials across 42 countries with 566 cities participating."

Answered by AI

Has AMN107 previously been tested in any clinical research studies?

"Preliminary research into AMN107 began in 2008 at Novartis Investigative Site, and over the past decade 79 clinical trials have been concluded. At present, 35 additional studies are actively recruiting participants; most notably across a variety of locations within Toronto, Canada."

Answered by AI

Has AMN107 received the regulatory blessing of the Food and Drug Administration?

"Owing to its Phase 4 designation, which implies the drug is already approved for use, our team at Power gave AMN107 a score of 3 on the safety scale."

Answered by AI

Is this experiment actively recruiting participants?

"This clinical trial is not accepting participants. The study was first posted on March 29, 2013 and most recently edited October 4th 2022. For those searching for other studies, there are currently two trials recruiting patients with GIST and CML, as well as thirty-five enrolling AMN107 users."

Answered by AI

How many people are currently participating in this clinical trial?

"At the present moment, this clinical trial is no longer accepting participants. It was first announced on March 29th 2013 and its info was last updated on October 4th 2022. If you are seeking other trials to join, there exist two GIST/CML studies and 35 AMN107 research projects that currently have open recruitment policies."

Answered by AI

What is the geographic scope of this research endeavor?

"Currently, this trial is recruiting participants from 6 different sites. These locations include Toronto, Vancouver and Houston among a few other medical centres. To ensure minimal transport demands are placed on the patient when enrolling, it's best to select a clinic closest to your location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
2013. "Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01735955.
~5 spots leftby Apr 2025
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