- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00535912
Phase III Study Treatment of CLL B and C
October 31, 2007 updated by: French Innovative Leukemia Organisation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: A
¨Chemotherapy by 12 courses of CHOP
|
|
Active Comparator: B
¨Chemotherapy by 3 courses of CHOP, intensification and autograft
|
Treatment by Intensive Chemotherapy and autograft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival
Time Frame: Overal survival
|
Overal survival
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response belong NIC criterias
Time Frame: 3 years after the end of treatment
|
3 years after the end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Annie BRION, RN, French Innovative Leukemia Organisation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
September 26, 2007
First Submitted That Met QC Criteria
September 26, 2007
First Posted (Estimate)
September 27, 2007
Study Record Updates
Last Update Posted (Estimate)
November 1, 2007
Last Update Submitted That Met QC Criteria
October 31, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LLC 98
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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