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

Toulouse University Hospital

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Treatments: Other: Telephone Intervention; Other: Usual Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT01393366

1030903

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Without AMA

Other group

Description:

Patient will be follow only like usual practice

Treatment:

Other: Usual Practice

With AMA

Other group

Description:

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

Treatment:

Other: Telephone Intervention