Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy
This trial is active, not recruiting.
|Condition||chronic lymphocytic leukemia|
|Treatments||telephone intervention, usual practice|
|Phase||phase 2/phase 3|
|Sponsor||University Hospital, Toulouse|
|Start date||September 2011|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01393366, 1030903|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
Evaluation of RDI
time frame: 3 years
Evaluation of Toxicity grade III-IV
time frame: 3 years
Male or female participants at least 18 years old.
Inclusion Criteria: 1. 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. 2. 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. 3. Signed informed consent 4. Age> or equal 18 years, ECOG PS 0-2. 5. Estimated overall survival>6 months. 6. Conserved liver function (bilirubin<2,5mg/dl, SGPT<4ULN, SGOT<4ULN) except infiltration due to the disease. 7. Contraception for younger patients. 8. Confident with the use of telephone, no disabling deafness. Exclusion Criteria: 1. Richter syndrome or atypical CLL (Matutes score <4), and/or del17p by FISH 2. Relapse of CLL 3. Contra-indications to fludarabine: auto-immune cytopenia, creatinine clearance<30 ml/mn. 4. Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal infection 5. Previous history of hypersensibility to any product used in this protocol 6. Denial, or medical or psychological condition preventing completion of the signed informed consent. 7. Treatment with an investigational agent, or participation to another therapeutic protocol, 30 days before participating to this study. 8. Pregnant/breastfeeding women. 9. CNS involvement by CLL. 10. Presence of another cancer needing treatment (except basocellular carcinoma or cervix cancer managed with only surgery or local therapy).
|Official title||Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy|
|Principal investigator||Loïc YSEBAERT, MD|
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