Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy

Inclusion criteria

• CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment.

• Matutes score must be 4-5/5.
• Initial cytopenia (due to CLL) are not exclusion criteria.
• Lymph node biopsy is needed only if suspicion of Richter syndrome.
• Mandatory pre-therapeutic check-up: FISH in search for deletion del17p and del11q, DAT test, haptoglobin levels, creatinine clearance.
• Eligibility to a treatment with FCR: clearance > 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score CIRS-G≤11.
• Signed informed consent
• Age> or equal 18 years, ECOG PS 0-2.
• Estimated overall survival>6 months.
• Conserved liver function (bilirubin<2,5mg/dl, SGPT<4ULN, SGOT<4ULN) except infiltration due to the disease.
• Contraception for younger patients.
• Confident with the use of telephone, no disabling deafness.

Exclusion criteria

• Richter syndrome or atypical CLL (Matutes score <4), and/or del17p by FISH
• Relapse of CLL
• Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance<30 ml/mn.
• Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection
• Previous history of hypersensibility to any product used in this protocol
• Denial, or medical or psychological condition preventing completion of the signed informed consent.
• Treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study.
• Pregnant/breastfeeding women.
• CNS involvement by CLL.
• Presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).