Phase III Study Treatment of CLL B and C

This study has been completed.
Sponsor:
Information provided by:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00535912
First received: September 26, 2007
Last updated: October 31, 2007
Last verified: September 2007

September 26, 2007
October 31, 2007
January 1999
Not Provided
progression free survival [ Time Frame: Overal survival ]
Same as current
Complete list of historical versions of study NCT00535912 on ClinicalTrials.gov Archive Site
response belong NIC criterias [ Time Frame: 3 years after the end of treatment ]
Same as current
Not Provided
Not Provided
 
Phase III Study Treatment of CLL B and C
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Lymphocytic, Chronic
Procedure: Stem cells autograft
Treatment by Intensive Chemotherapy and autograft
  • No Intervention: A
    ¨Chemotherapy by 12 courses of CHOP
  • Active Comparator: B
    ¨Chemotherapy by 3 courses of CHOP, intensification and autograft
    Intervention: Procedure: Stem cells autograft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
March 2006
Not Provided

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00535912
LLC 98
Yes
Not Provided
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Not Provided
Principal Investigator: Annie BRION, RN Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP