Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients (PETALs)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02201459 |
Recruitment Status : Unknown
Verified August 2014 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : July 28, 2014
Last Update Posted : August 7, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Myeloid Leukemia | Drug: Nilotinib (Tasigna ®), capsules of 150 mg Drug: Nilotinib (Tasigna ®) and Pegylated interferon alfa 2a (Pegasys®) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | January 2018 |
Estimated Study Completion Date : | August 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Nilotinib
Control arm, this compound been licensed in this indication.
|
Drug: Nilotinib (Tasigna ®), capsules of 150 mg
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 |
Experimental: Peg-IFN alfa 2a (Pegasys®) and Nilotinib
Arm testing the efficacy of a combination of nilotinib and Peg-IFN alfa 2a as frontline therapy for first line chronic phase CML patients.
|
Drug: Nilotinib (Tasigna ®), capsules of 150 mg
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 Drug: Nilotinib (Tasigna ®) and Pegylated interferon alfa 2a (Pegasys®)
|
- 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
- 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.
- 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.
- 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.
- 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)
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Progression-free survival [ Time Frame: 36 months ]Survival without progression towards accelerated of blast phase, death.
- Overall survival. [ Time Frame: 36 months ]Survival without death from any cause

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201459
Contact: Madeleine ETIENNE, CRA | 4 78 86 22 32 ext +33 | madeleine.etienne@chu-lyon.fr | |
Contact: jérémy MONFRAY, CRA | 4 78 86 22 27 ext +33 | jeremy.monfray@chu-lyon.fr |
France | |
Franck NICOLINI | Recruiting |
Lyon, France, 04 78 86 22 50 | |
Contact: Franck Nicolini, MD 4 78 86 22 50 ext 33 franck-emmanuel.nicolini@chu-lyon.fr |
Principal Investigator: | Franck NICOLINI, MD | Hopsices Civils de Lyon |
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT02201459 |
Other Study ID Numbers: |
2013.837 |
First Posted: | July 28, 2014 Key Record Dates |
Last Update Posted: | August 7, 2014 |
Last Verified: | August 2014 |
Peg-IFN, nilotinib, MR4.5, CML, chronic phase, first-line |
Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Interferons |
Interferon-alpha Interferon alpha-2 Peginterferon alfa-2a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |