Status:
COMPLETED
Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients
Lead Sponsor:
Hospices Civils de Lyon
Collaborating Sponsors:
Novartis
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 imp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02201459
Start Date
August 1 2014
End Date
October 1 2022
Last Update
October 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Franck NICOLINI
Lyon, France, 04 78 86 22 50