Phase III Study Treatment of CLL B and C

NCT ID: NCT00535912

Last Updated: 2007-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2006-03-31

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.

Conditions

Leukemia, Lymphocytic, Chronic

Keywords

CLL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

¨Chemotherapy by 12 courses of CHOP

Group Type: NO_INTERVENTION

No interventions assigned to this group

B

¨Chemotherapy by 3 courses of CHOP, intensification and autograft

Group Type: ACTIVE_COMPARATOR

Stem cells autograft

Intervention Type: PROCEDURE

Treatment by Intensive Chemotherapy and autograft

Interventions

Stem cells autograft

Treatment by Intensive Chemotherapy and autograft

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Innovative Leukemia Organisation

OTHER

Sponsor Role: lead

Principal Investigators

Annie BRION, RN

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Other Identifiers

LLC 98

Identifier Type: -

Identifier Source: org_study_id