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

Chronic Lymphocytic Leukemia Clinical Trial

— FORTIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393366
• Other study ID #: 1030903
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: December 2016

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell

Intervention

Other:
• Telephone Intervention
Only for arm AMA, patient will have one phone every week to evaluate physical conditions.
• Usual Practice
None, only usual practice.

Locations

Country	Name	City	State
France	Centre Hospitalier de la côte basque	Bayonne
France	CH Saint Jean	Perpignan
France	CHU Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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 lymphocyti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of RDI	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.	3 years
Secondary	Evaluation of Toxicity grade III-IV	rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.	3 years