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

Study Overview
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Brief Summary
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The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.

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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Other: Telephone Intervention
* Other: Usual Practice


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Without AMA<br>Patient will be follow only like usual practice | Other: Usual Practice<br>* None, only usual practice.<br>|
| Other: With AMA<br>Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions. | Other: Telephone Intervention<br>* Only for arm AMA, patient will have one phone every week to evaluate physical conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of RDI | Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Toxicity grade III-IV | rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy. | 3 years |