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Tyrosine Kinase Inhibitor

Nilotinib Treatment-Free Remission for Chronic Myeloid Leukemia (ENESTfreedom 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

Minimum of 2 calendar years of nilotinib treatment with at least the last 12 months of nilotinib treatment prior to pre-screening at approved total daily dose of 600 mg BID or at a reduced dose of 400 mg QD if required from the perspective of tolerance for BCR-ABL positive CML in documented chronic phase at the time of diagnosis

Evidence of typical BCR-ABL transcripts (b3a2 and/or b2a2) at the time of CML-CP diagnosis i.e. prior to first start of TKI treatment which are amenable to standardized RT-PCR quantification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48, 96, 144, 192, 264 weeks, end of 6, 7, 8, 9 and 10 years

Awards & highlights

ENESTfreedom Trial Summary

This trial looked at whether patients with a specific type of leukemia could safely stop taking a certain medication without the leukemia coming back.

Who is the study for?

Adults diagnosed with chronic phase Chronic Myeloid Leukemia (CML) who have been treated with nilotinib for at least two years and are in deep molecular response. They must have normal organ and marrow function, no history of pancreatitis or uncontrolled diabetes, not be pregnant or breastfeeding, and cannot be on certain medications that affect liver enzymes or prolong the QT interval.Check my eligibility

What is being tested?

The trial is testing if patients with CML who respond well to nilotinib can safely stop treatment without the disease coming back. Participants will first receive nilotinib until they achieve a specific level of response before attempting a treatment-free period.See study design

What are the potential side effects?

Nilotinib may cause side effects such as rash, nausea, headache, fatigue, itching, vomiting, diarrhea, coughing up blood; it can also affect blood sugar levels and heart rhythm.

ENESTfreedom Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with nilotinib for my CML for at least 2 years, including the last 12 months.

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My CML was confirmed with specific genetic markers before starting TKI treatment.

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I am able to get out of my bed or chair and move around.

ENESTfreedom Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48, 96, 144, 192, 264 weeks, end of 6, 7, 8, 9 and 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48, 96, 144, 192, 264 weeks, end of 6, 7, 8, 9 and 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48, 96, 144, 192, 264 weeks, end of 6, 7, 8, 9 and 10 years for reporting.

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 Who Are in MMR (Major Molecular Response) at 48 Weeks After Starting the Treatment-free Remission (TFR) Phase

Secondary outcome measures

Duration of Re-initiated Treatment Required to Regain MMR After Loss of MMR

Duration of Re-initiated Treatment Required to Regain MR4.5 After Loss of MMR

Kinetics of BCR-ABL Transcript After Re-start of Nilotinib Therapy

+12 more

ENESTfreedom Trial Design

1Treatment groups

Experimental Treatment

Group I: Nilotinib followed by treatment-freeExperimental Treatment1 Intervention

Patients who received a minimum of 2 years of first line nilotinib treatment and with pre-screen PCR results in ≥ MR4.5 entered the consolidation phase of the study (52 weeks - nilotinib 300 mg BID). Patients with Minimal Residual Disease (MRD) at the end of this phase entered the Treatment-Free Remission (TFR) phase where no treatment was given. Non eligible patients will enter the continuation phase of the study. Patients with MRD at the end of the continuation phase will enter the TFR-2 phase of the study where no treatment is given. Non eligible patients will enter the prolonged continuation phase of the study. If at any time during TFR or TFR-2 the patient loses MMR, nilotinib treatment will be immediately re-initiated (nilotinib 300 mg BID).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,135 Total Patients Enrolled

151 Trials studying Leukemia

23,617 Patients Enrolled for Leukemia

Media Library

Nilotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01784068 — Phase 2

Leukemia Research Study Groups: Nilotinib followed by treatment-free

Leukemia Clinical Trial 2023: Nilotinib Highlights & Side Effects. Trial Name: NCT01784068 — Phase 2

Nilotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01784068 — Phase 2

Frequently Asked Questions

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

What is the current population size of participants in this trial?

"At present, this clinical trial is not enrolling. It was initially posted on March 4th 2013 and most recently updated on April 25th 2022. If searching for alternative trials, 1453 studies are currently seeking participants with myelogenous chronic bcr-abl positive leukemia while 35 separate medical research projects are actively recruiting people who have undergone Nilotinib treatment followed by a period of remission."

Answered by AI

Is this test a pioneering endeavor?

"Since 2008, the efficacy of nilotinib followed by treatment-free has been meticulously studied and Novartis Pharmaceuticals initially sponsored its flagship trial. By Phase 4 approval in 2020, 35 trials had commenced across 42 countries and 566 cities."

Answered by AI

In what capacity are the participating sites running this experiment?

"This investigation is active at 10 different sites, which are located in New york, Fort Myers, Miami Lakes and other cities. To reduce travel commitment for participants who join this trial it may be beneficial to pick a site close by."

Answered by AI

Does Nilotinib combined with a treatment-free approach pose any potential risks to patients?

"Based on available information, the safety of nilotinib followed by treatment-free is rated a 2; there is prior evidence supporting its security but no data regarding efficacy."

Answered by AI

Are there any precedents of Nilotinib being recommended as a first-line treatment followed by maintenance?

"At present, there are 35 active clinical trials for Nilotinib followed by treatment-free, 6 of which have reached Phase 3. While the majority of these studies take place in Fukuoka city, Fukuoka, 1548 locations around the world currently operate related trials."

Answered by AI

Are recruitment opportunities still available for this clinical trial?

"Unfortunately, this clinical trial has ceased recruitment. It was first posted on March 4th 2013 and last updated April 25th 2022. Should you wish to search for other studies, 1453 trials are presently accepting patients with chronic myelogenous leukemia bcr-abl positive, while 35 studies allow enrollment of those seeking treatment with Nilotinib followed by treatment-free care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients

2013. "Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01784068.

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