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

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Nilotinib (Tasigna ®), capsules of 150 mg; Drug: Nilotinib (Tasigna ®) and Pegylated interferon alfa 2a (Pegasys®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02201459

2013.837

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Nilotinib

Active Comparator group

Description:

Control arm, this compound been licensed in this indication.

Treatment:

Drug: Nilotinib (Tasigna ®), capsules of 150 mg

Peg-IFN alfa 2a (Pegasys®) and Nilotinib

Experimental group

Description:

Arm testing the efficacy of a combination of nilotinib and Peg-IFN alfa 2a as frontline therapy for first line chronic phase CML patients.

Treatment:

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

Drug: Nilotinib (Tasigna ®), capsules of 150 mg