NCT01393366已完成不适用
Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Evaluation of RDI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment.
- •Matutes score must be 4-5/
- •Initial cytopenia (due to CLL) are not
排除标准
- •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≤
- •Signed informed consent
- •Age> or equal 18 years, ECOG PS 0-
- •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).
研究组 & 干预措施
Without AMA
Other
Patient will be follow only like usual practice
干预措施: Usual Practice (Other)
With AMA
Other
Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.
干预措施: Telephone Intervention (Other)
结局指标
主要结局
Evaluation of RDI
时间窗: 3 years
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.
次要结局
- Evaluation of Toxicity grade III-IV(3 years)
研究者
研究点 (3)
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