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Phase III Study Treatment of CLL B and C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00535912
First Posted: September 27, 2007
Last Update Posted: November 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
French Innovative Leukemia Organisation
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by French Innovative Leukemia Organisation:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535912


Sponsors and Collaborators
French Innovative Leukemia Organisation
Investigators
Principal Investigator: Annie BRION, RN French Innovative Leukemia Organisation
  More Information

ClinicalTrials.gov Identifier: NCT00535912     History of Changes
Other Study ID Numbers: LLC 98
First Submitted: September 26, 2007
First Posted: September 27, 2007
Last Update Posted: November 1, 2007
Last Verified: September 2007

Keywords provided by French Innovative Leukemia Organisation:
CLL

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