Clinical trial · Interventional
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy
Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
NCT01393366CI-TRIAL-00106954FORTIScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telephone Intervention | Other | — | UNRESOLVED |
| Usual Practice | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Without AMA
- description
- Patient will be follow only like usual practice
- interventionNames
- Other: Usual Practice
- type
- OTHER
- label
- With AMA
- description
- Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.
- interventionNames
- Other: Telephone Intervention
Primary outcomes (1)
- measure
- Evaluation of RDI
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTYsebaert L, Larcher M, Compaci G, Oberic L, Sahnes L, Banos A, Araujo C, Sommet A, Laurent G, Despas F. Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia. Ann Hematol. 2019 Apr;98(4):931-939. doi: 10.1007/s00277-019-03631-z. Epub 2019 Feb 18. PMID 30778715