Clinical trial NCT00718549: A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)
Official title: A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With Mabthera (Rituximab) Versus No Treatment, After Induction Treatment With Rituximab, Cladribine and Cyclophosphamide (RCC) on Progression-Free Survival in Previously Untreated Patients With Progressive B-Cell Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.


Eligibility criteria: Inclusion Criteria:

* Immunologically confirmed diagnosis of B-cell CLL
* Rai stage I-IV disease with evidence of progression
* No previous chemotherapy, radiotherapy, or immunotherapy for B-cell CLL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

* Active secondary malignancy or transformation to aggressive lymphoma
* Medical condition requiring chronic use of oral corticosteroids at a dose of 1 mg/kg or 60 mg/m\^2 over 2 weeks
* Prior treatment with interferon, rituximab or another monoclonal antibody, immunosuppressive treatment or radiotherapy before inclusion to the study
* History of other malignancies within 2 years before study entry, except for dequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent

Primary outcomes:
measure: Percentage of Participants With Disease Progression (PD), Relapse, or Death Due to Any Cause Assessed According to the National Cancer Institute (NCI) Revised Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia (CLL)
timeFrame: From randomization to PD, Relapse, or death due to any cause (overall approximately 5 years)
measure: Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL
timeFrame: From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)
Secondary outcomes:
measure: Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL
timeFrame: 8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)
measure: Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR
timeFrame: 8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)
measure: PFS Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors
timeFrame: From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)
measure: Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 29
timeFrame: 8 weeks after the last dose of rituximab during induction treatment (Week 29)
measure: Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 129
timeFrame: 12 weeks after the end of maintenance treatment or observation phase (Week 129)
measure: Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 29
timeFrame: 8 weeks after the last dose of rituximab during induction treatment (Week 29)
measure: Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 129
timeFrame: 12 weeks after the end of maintenance treatment or observation phase (Week 129)
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: City Clinical Hospital #9
city: Bialystok
country: Poland
facility: Medical University, Independent Public Clinical Hospital; Dept. of Hematology, SPSK
city: Krakow
country: Poland
facility: Szpital Uniwersytecki W Krakowie; Klinika Hematologii
city: Lodz
country: Poland
facility: Medical University School; Dept. of Haematology
city: Warszawa
country: Poland
facility: Istytut Hematologii i Transfuzjologii; Hematologia
city: Wroclaw
country: Poland
facility: Medical Uni of Wroclaw; Hematology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: