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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Leukemia, Lymphocytic, Chronic
 Procedure: Stem cells autograft
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • progression free survival [ Time Frame: Overal survival ]

Secondary Outcome Measures:
  • response belong NIC criterias [ Time Frame: 3 years after the end of treatment ]

Enrollment: 140
Study Start Date: January 1999
Study Completion Date: March 2006
Arms Assigned Interventions
No Intervention: A
¨Chemotherapy by 12 courses of CHOP
Active Comparator: B
¨Chemotherapy by 3 courses of CHOP, intensification and autograft
 Procedure: Stem cells autograft
Treatment by Intensive Chemotherapy and autograft

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535912

Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Annie BRION, RN Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00535912     History of Changes
Other Study ID Numbers: LLC 98
Study First Received: September 26, 2007
Last Updated: October 31, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013