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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
B-cell Chronic Lymphocytic Leukemia CLL

Thank you

Trial Information

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


Young fit medically B Cell untreated patients Comparison between FCR treatment = 6 FCR
cycles and a the addition of a prephase with R Dense treatment before the 6 FCR cycles.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete response rates according to IWCLL 2008 guidelines with undetectable minimal residual disease

Outcome Description:

CR MRD negative rate at 9 months = treatment evaluation surveillance of cumulative toxicities of high dose rituximab

Outcome Time Frame:

9 months

Safety Issue:

Yes

Principal Investigator

Guillaume CARTRON, MD PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

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

Study ID:

CLL 2010 FMP

NCT ID:

NCT01370772

Start Date:

May 2011

Completion Date:

December 2017

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia CLL
  • B CLL
  • Fist line treatment
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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