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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01393366

Acronym

FORTIS

Enrollment

Registered

2011-07-13

Start date

2011-09-01

Completion date

2016-12-01

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

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.

Interventions

OTHERTelephone Intervention

Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

OTHERUsual Practice

None, only usual practice.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of RDI	3 years	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.

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLoïc YSEBAERT, MD

University Hospital Of Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026