EUCTR2012-003389-42-FR
Active, not recruiting
Not Applicable
A phase II study to assess the efficacy and safety of frontline combination of dasatinib (SPRYCEL®) and pegylated-interferon alpha 2b (Peg-IFNa2b) therapy in patients newly diagnosed with chronic phase chronic myeloid leukaemia (CP-CML) - DASA-PEGIF
ConditionsPatients with newly diagnosed chronic phase Chronic Myeloid Leukemia (CP-CML), not previously treated with Tyrosine Kinase Inhibitors (TKIs). First line therapy.MedDRA version: 14.1Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with newly diagnosed chronic phase Chronic Myeloid Leukemia (CP-CML), not previously treated with Tyrosine Kinase Inhibitors (TKIs). First line therapy.
- Sponsor
- CHU DE POITIERS
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Principal inclusion criteria
- •1\)Signed Written Informed Consent: All patients must have read and sign the informed consent form (ICF) before any procedure related to the study, registration/inclusion in the study.
- •2\)Target Population
- •a)Men and women, ages 18 to 69 years
- •b)Newly diagnosed (\= 3 months) Philadelphia chromosome positive chronic phase chronic myeloid leukemia (CP\-CML)
- •c)Major BCR\-ABL transcripts (p210 b2a2 or b3a2\)
- •d)Not previously treated for CML except with hydroxyurea or anagrelide
- •e)ECOG Performance Status (ECOG PS) \= 2
- •f)Adequate Organ Function.
- •i)Total bilirubin \< 2\.0 times the institutional Upper Limit of Normal (ULN)
Exclusion Criteria
- •1\)Patients with BCR\-ABL other than M\-BCR\-ABL, Philadelphia negative CML.
- •2\)Patients previously treated with Tyrosine Kinase Inhibitors (TKIs).
- •3\)Medical history and concurrent diseases:
- •a)Prior treatment with Interferon\-a / Contraindication to interferon\-a,
- •b)Concomitant immunosuppressive treatment or corticosteroids,
- •c)Preexisting thyroid disease unless it is controlled with conventional treatment, Auto\-immune thyroiditis,
- •d)Autoimmune disorder, Chronic liver disease,
- •e)Prior or ongoing severe psychiatric disease,
- •f)Epilepsy or compromised central nervous system(CNS) function,
- •g)HIV positivity, chronic hepatitis B or C,
Outcomes
Primary Outcomes
Not specified
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