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.
- 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.
- 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).
|Official title||Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy|
|Principal investigator||Loïc YSEBAERT, MD|
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