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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 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).

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,199,111 Total Patients Enrolled
152 Trials studying Leukemia
23,734 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
~18 spots leftby May 2025
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