Phase III Study Treatment of CLL B and C

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00535912

Enrollment

140

Registered

2007-09-27

Start date

1999-01-31

Completion date

2006-03-31

Last updated

2007-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphocytic, Chronic

Keywords

CLL

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.

Interventions

PROCEDUREStem cells autograft

Treatment by Intensive Chemotherapy and autograft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
progression free survival	Overal survival

Secondary

Measure	Time frame
response belong NIC criterias	3 years after the end of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026