Phase III Study Treatment of CLL B and C

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Leukemia, Lymphocytic, Chronic

Intervention / Treatment
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* Procedure: Stem cells autograft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>¨Chemotherapy by 12 courses of CHOP | |
| Active Comparator: B<br>¨Chemotherapy by 3 courses of CHOP, intensification and autograft | Procedure: Stem cells autograft<br>* Treatment by Intensive Chemotherapy and autograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | Overal survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response belong NIC criterias |  | 3 years after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL