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Completed

NCT Number: NCT02201459

Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients

This is a phase III trial comparing, for newly diagnosed chronic phase CML patients, nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa 2 a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is the rate patients obtaining MR4.5 will be measured at this time point.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Franck NICOLINI

Lyon, 04 78 86 22 50, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients
  • CP-CML, positive Philadelphia chromosome or positive BCR-ABL (M-bcr transcript), diagnosed less than 3 months prior to study entry
  • Age of at least 18 years-old and less than 65 years
  • Patient for whom treatment with Nilotinib is expected
  • No other CML treatment except for hydroxyurea and/or anagrelide
  • No previous TKI treatment.
  • No previous treatment with IFN even for other purposes.
  • SGOT and SGPT < 2.5 UNL
  • Serum creatinine < 2 UNL
  • No planned allogeneic stem cell transplantation
  • Signed informed consent
  • ECOG score 0 to 2

Exclusion criteria

  • Contra-indication to IFN
  • Transcripts other than M-Bcr
  • Pregnancy, lactation
  • HIV positivity, chronic hepatitis B or C.
  • Prior or concurrent malignancy other than CML (exceptions to be mentioned)
  • History of arterial occlusive disease or (peripheral, carotids or severe coronary heart disease).
  • Permanent elevation of total cholesterol and triglycerides despite treatment
  • Severe psychiatric/neurological disease (previous or ongoing)
  • Concomitant auto-immune disease
  • Other investigational product ongoing
  • Ongoing immunosuppressive treatment
  • Ongoing treatment at risk for inducing torsades de pointes
  • QTcF > 450ms despite correction of predisposing factors (i.e electrolytes…)
  • Congenital long QTcF
  • Unstabilised thyroid disorder
  • No health insurance coverage

Treatment and study plan

Nilotinib (Tasigna ®), capsules of 150 mg

Drug

Nilotinib 2 capsules of 150 mg orally twice daily at 12 hours difference, fasting (minimum 1 hour before or 2 hours after a meal) for at least 36 months

Nilotinib (Tasigna ®) and Pegylated interferon alfa 2a (Pegasys®)

Drug
  • Nilotinib 2 capsules of 150 mg orally twice daily at 12 hours difference, fasting (minimum 1 hour before or 2 hours after a meal) for at least 36 months and
  • Pegylated interferon alfa 2a subcutaneously once a week (auto-injection syringes of 135 and 90 micrograms) at 30 micrograms/week the first month alone (= priming procedure), then at 30 micrograms/2weeks the first month of combination to nilotinib and then at 45 micrograms/week thereafter until month 24 after nilotinib initiation.

Primary outcomes

  1. Molecular response (MR) 4.5 at 12 months of nilotinib 300 mg twice a day versus a combination of low-dose Peg-Interferon (Peg-IFN) to nilotinib 300 mg twice a day in newly diagnosed CP-CML Chronic Phase Chronic Myelogenous Leukemia patients.

    Time frame: 12 months

    Centralised assessment of the BCR-ABL transcripts at 12 months since nilotinib initiation

Secondary outcomes

  1. Molecular Response 4.5 at 1, 2, 3, 6, 9, 12 months of nilotinib, and duration of MR4.5 during the second year of treatment (18, 24 and 36 months).

    Time frame: 36 months

    Centralised assessment of the BCR-ABL transcripts every month for 3 months and every three months until 12 months and thereafter every 6 months until 36 months assessment.

  2. Major Molecular Response at 1, 2, 3, 6, 9, 12 months of nilotinib, and duration of MMR during the second year of treatment (18, 24 and 36 months).

    Time frame: 36 months

    Centralised assessment of the BCR-ABL transcripts every month for 3 months and every three months until 12 months and thereafter every 6 months until 36 months assessment.

  3. Rate of patients with BCR-ABL/ABL (IS) ≥10% at 3 months.

    Time frame: 3 months after nilotinib initiation

    Centralised assessment of the BCR-ABL transcripts at 3 months.

  4. Rate of CCyR (complete cytogenetic responses: bone marrow Philadelphie positive at 0 % on at least 20 metaphases) at 3, 6, 12 months of nilotinib.

    Time frame: Assessment at 3, 6 and 12 months

    Local bone marrow cytogenetic assessment (on 20 metaphases)

  5. Safety of the nilotinib combined to Peg-IFN or not (hematological and non-hematological adverse events (AE) graded according to the NCI CTC AE v3).

    Time frame: 36 months

    Continuous evaluation of the AEs and SAEs reported during 36 months

  6. Quality of life of patients treated in both arms

    Time frame: 36 months

    EORTC-QLQ C30 and C24 questionnaire at months -1 (Arm B), month 0, 1, 6, 12, 24, 36.

  7. Doses-reductions/interruptions of drugs in both arms. Mean daily doses of nilotinib and Peg-IFN administered.

    Time frame: 24 months for Peg-IFN, and 36 months for both drugs

    Continuous recording of dose intensity along the study for 24-36 months.

  8. Compliance to drugs in each arms

    Time frame: 36 months

    Morisky questionnaire to be fulfilled at 1, 6, 12, 24 and 36 months after nilotinib initiation.

  9. Molecular relapse rate at 6 and 12 months after nilotinib withdrawal in patients obtaining 2-year stable MR4.5.

    Time frame: 36 months

    Local (but standardized) assessment of the BCR-ABL transcripts every months for 3 months.

  10. Event-free survival.

    Time frame: 36 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.

  11. Progression-free survival

    Time frame: 36 months

    Survival without progression towards accelerated of blast phase, death.

  12. Overall survival.

    Time frame: 36 months

    Survival without death from any cause

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Novartis

Registry information

Official study title

Randomized Multicenter Phase III Study Comparing the Rate of Molecular Response 4.5 at 12 Months in Newly Diagnosed Philadelphia Positive Chronic Phase Chronic Myelogenous Leukemia Patients Receiving Either Frontline Nilotinib 600 mg Daily or Nilotinib 600 mg Daily Combined to Pegylated Interferon-alfa 2a (Peg-IFN)

Acronym: PETALs

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2014
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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