Phase III Study Treatment of CLL B and C

NCT00535912 | Completed Phase 3 DMC

• 1 other identifier: LLC 98
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia, Lymphocytic, Chronic

Keywords

CLL

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Overal survival

Secondary Outcomes (1)

• response belong NIC criterias

  3 years after the end of treatment

Study Arms (2)

A

NO INTERVENTION

¨Chemotherapy by 12 courses of CHOP

B

ACTIVE COMPARATOR

¨Chemotherapy by 3 courses of CHOP, intensification and autograft

Procedure: Stem cells autograft

Interventions

Stem cells autograft PROCEDURE

Treatment by Intensive Chemotherapy and autograft

B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annie BRION, RN

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 27, 2007
• Study Start: January 1, 1999
• Study Completion: March 1, 2006
• Last Updated: November 1, 2007

Record last verified: 2007-09