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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Without AMA

Patient will be follow only like usual practice

Group Type OTHER

Usual Practice

Intervention Type OTHER

None, only usual practice.

With AMA

Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.

Group Type OTHER

Telephone Intervention

Intervention Type OTHER

Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

Interventions

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Telephone Intervention

Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

Intervention Type OTHER

Usual Practice

None, only usual practice.

Intervention Type OTHER

Eligibility Criteria

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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.

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.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No