Phase III Study Treatment of CLL B and C

Leukemia, Lymphocytic, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535912
• Other study ID #: LLC 98
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2007
• Last updated: October 31, 2007
• Start date: January 1999
• Est. completion date: March 2006

Study information

• Verified date: September 2007
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Procedure:
• Stem cells autograft
Treatment by Intensive Chemotherapy and autograft

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		Overal survival
Secondary	response belong NIC criterias		3 years after the end of treatment