Clinical trial NCT01393366: Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy
Official title: Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Evaluation of RDI
timeFrame: 3 years
Secondary outcomes:
measure: Evaluation of Toxicity grade III-IV
timeFrame: 3 years
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre Hospitalier de la côte basque
city: Perpignan
country: France
facility: CH Saint Jean
city: Toulouse
country: France
facility: CHU Purpan
Study officials:
affiliation: University Hospital Of Toulouse
name: Loïc YSEBAERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ysebaert 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.