Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01393366
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01393366
Study Brief:
Protocol Section:
NCT01393366