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Phase III Study Treatment of CLL B and C

Sponsor
French Innovative Leukemia Organisation (Other)
Overall Status
Completed
CT.gov ID
NCT00535912
Collaborator
(none)
140
Enrollment
2
Arms
85.9
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stem cells autograft
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
140 participants
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
Study Start Date :
Jan 1, 1999
Actual Study Completion Date :
Mar 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. progression free survival [Overal survival]

Secondary Outcome Measures

  1. response belong NIC criterias [3 years after the end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Annie BRION, RN, French Innovative Leukemia Organisation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00535912
Other Study ID Numbers:
  • LLC 98
First Posted:
Sep 27, 2007
Last Update Posted:
Nov 1, 2007
Last Verified:
Sep 1, 2007
Keywords provided by , ,
CLL
Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Nov 1, 2007