Clinical trial NCT00535912: Phase III Study Treatment of CLL B and C
Official title: A Multicentric Phase III Study in Patients With CLL B and C < 60 Years Not Treated: 6 Montly CHOP + 6 CHOP Every 3 Months Versus 3 Montly CHOP + Intensification and Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia, Lymphocytic, Chronic
Keywords: CLL
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in case of response. Experimental arm consisted of high dose therapy with autologous CD34+ purified progenitor cell support, used as consolidation of Complete Remission or Very Good Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses of fludarabine in case of insufficient response.

Detailed description: The aim of the prospective randomized GOELAMS LLC 98 trial reported here was to compare two therapeutic strategies in previously untreated B and C Binet stages B-CLL patients less than 60 years old. Conventional chemotherapy (Arm A) consisted of six monthly courses of CHOP, i.e. vincristin IV 1 mg/m2 on day 1, doxorubicin IV 25 mg/m2 on day 1, cyclophosphamide (Cy) 300 mg/m2 and prednisone 40 mg/m2 both given orally from day 1 to day 5, followed by 6 CHOP courses every other 3 months in case of response. Fludarabine (25 mg/m2 /d IV for 5 consecutive days) was used in case of non response (stable disease or progression) after 3 CHOP courses. This conventional therapy was compared to high dose therapy with autologous CD34+ purified progenitor cell support (Arm B), used as consolidation of Complete Remission (CR) or Very Good Partial Response (VGPR, defined by \>50 % tumoral response and bone marrow lymphocyte infiltration \<30%) obtained after 3 monthly courses of CHOP. In the absence of CR or VGPR, 3 to 6 monthly-courses of fludarabine were performed before mobilization with Cy 4 g/m2 + G-CSF administration. The conditioning regimen included TBI 12 Gy and Cy 60 mg /kg /d for 2 days.

Eligibility criteria: Inclusion Criteria:

* CLL with Lymphocitis \> 15.10 9/L
* B-CLL stage B or C
* Patients \> 18 years old and \< 60 years old
* No previous treatment of CLL
* ECOG performance status \< 2
* Good cardiac function
* Patient's written informed consent

Exclusion Criteria:

* B-CLL stage A
* Age \> 60 years old
* previous treatment of CLL
* ECOG performance status \> 2
* Cardiac or pneumo Insufficency
* hepatic or renal Insufficency
* Seropositivity HIV
* Previous other malignancy
* Fertile male and female patients who cannot or do not wish to use an effective method of contraception
* Any coexisting medical or psychological condition that would preclude participation to the required study procedures
* NOt signed Patient's informed consent

Primary outcomes:
measure: progression free survival
timeFrame: Overal survival
Secondary outcomes:
measure: response belong NIC criterias
timeFrame: 3 years after the end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Annie BRION, RN
role: PRINCIPAL_INVESTIGATOR
References: