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

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Patient will be follow only like usual practice
usual practice
None, only usual practice.
Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.
telephone intervention
Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

Primary Outcomes

Evaluation of RDI
time frame: 3 years

Secondary Outcomes

Evaluation of Toxicity grade III-IV
time frame: 3 years

Eligibility Criteria

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).

Additional Information

Official title Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
Principal investigator Loïc YSEBAERT, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Hospital, Toulouse.