Intensified Rituimab Prephase Before FCR in Untreated B-CLL

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT01370772
• Date of registration: 23/05/2011
• Prospective Registration: No
• Primary sponsor: French Innovative Leukemia Organisation
• Public title: Intensified Rituimab Prephase Before FCR in Untreated B-CLL
• Scientific title: Phase II Multicentric, Randomized Trial, Exploring Intensified Rituximab Prephase Monotherapy Before Standard Fludarabine-Cyclophosphamide-Rituximab Regimen in Previously Untreated Symptomatic B-cell Chronic Lymphocytic Leukemia
• Date of first enrolment: May 2011
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01370772
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Guillaume CARTRON, MD PD
• Affiliation: French Innovative Leukemia Organisation

• Name: Stephane LEPRETRE, MD
• Affiliation: French Innovative Leukemia Organisation

Key inclusion & exclusion criteria

Inclusion criteria:

- Patient information and written informed consent

- 18 years < Age < 66 ans

- confirmed B-CLL Matutes score 4 or 5

- Binet stage C or Binet stage A and B with active disease could be considered for
inclusion. For stage A with active disease an agreement of investigator coordinator
is required.

- no prior treatment except steroids for less than 1 month (detail corticoid)

- No 17p deletion as assessed by FISH < 10 % positive nuclei

- Performance status ECOG < 2

- CIRS Cumulative Illness Rating Scale < 6

Exclusion criteria:

- Binet stage A without active disease according to IWCLL 2008 criteria

- Know HIV seropositivity

- Hepatitis B or C seropositivity unless clearly due to vaccination

- Life expectancy < 6 months

- Clinically significant auto-immune anemia

- Active second malignancy currently requiring treatment (except basal cell carcinoma
in situ endometrial carcinoma and incidental prostate carcinoma) and/or less than 5
years CR after breast cancer

- Any severe co-morbid conditions such as Class III or IV heart failure, myocardial
infarction within 6 months, unstable angina, ventricular tachyarythmias requiring
ongoing treatment, severe chronic obstructive pulmonary disease with hypoxemia,
uncontrolled diabetes mellitus, or uncontrolled hypertension

- Concomitant disease requiring prolonged use of corticosteroids > 1 month

- Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies
or any of the study drugs According to the SmPC or investigator practice

- Contraindication to use of Rituximab

- Transformation to aggressive B-cell malignancy e.g. diffuse large cell lymphoma,
Hodgkin lymphoma, or prolymphocytic leukaemia

- Active bacterial, viral or fungal infection

- Abnormal renal function with creatinine clearance < 60 ml/min calculated according to
the Cockcroft and Gault formula

- Total bilirubin, gamma glutamyltransferase or transaminase levels > 2.5 ULN.

- Any coexisting medical or psychological condition that would preclude participation
in the required study procedures

- Patient with mental deficiency preventing proper understanding of the requirements of
treatment.

- Pregnant or breastfeeding women.

- Adult under law-control

- Fertile male and female patients who cannot or do not wish to use an effective method
of contraception, during and for 12 months after the final treatment used for the
purposes of the study.

- No afiliate to social security



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

B-cell Chronic Lymphocytic Leukemia CLL

Intervention(s)

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: Rituximab

Primary Outcome(s)

complete response rates according to IWCLL 2008 guidelines with undetectable minimal residual disease [Time Frame: 9 months]

Secondary Outcome(s)

evaluate the immunophenotypic response rate after high dose Rituximab alone prephase in DenseR-FC [Time Frame: 9 months]

To determine and compare the progression free survival PFS [Time Frame: 3 years]

To determine and compare the disease-free survival DFS [Time Frame: 3 years]

To determine the time to next treatment TTNT [Time Frame: 3 years]

To determine the overall survival OS [Time Frame: 3 years]

To evaluate FcyRs polymorphisms influence on clinical response [Time Frame: 9 months]

To determine the event-free survival EFS [Time Frame: 3 years]

To determine the pharmacokinetics of rituximab and determine the PK-PD relationship of rituximab based on biomarkers. [Time Frame: 12 months]

To evaluate the safety profile of higher doses of rituximab [Time Frame: 41]

Secondary ID(s)

CLL 2010 FMP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG