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

Phase 2/Phase 3
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

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Trial Information

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

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

4. Serologies positive for HIV, HBV, or HCV. No active bacterial, viral or fungal

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).

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Evaluation of RDI

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Of Toulouse


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

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