A Study of Maintenance Treatment With MabThera (Rituximab) in Patients With Progressive B-cell Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00718549
First received: July 16, 2008
Last updated: August 26, 2014
Last verified: August 2014

July 16, 2008
August 26, 2014
July 2009
July 2017   (final data collection date for primary outcome measure)
Progression-free survival in the maintenance phase [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00718549 on ClinicalTrials.gov Archive Site
Complete response and partial response in induction phase [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Maintenance Treatment With MabThera (Rituximab) in Patients With Progressive B-cell Chronic Lymphocytic Leukemia
A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With MabThera vs no Treatment, After Induction With MabThera, Cladribine and Cyclophosphamide on Progression-free Survival in Previously Untreated Patients With Progressive B-CLL. The Trial Conducted With PALG Sites

This study will assess the effect of maintenance treatment with MabThera,in comp arison with a 2 year observation period (no treatment),in patients with progress ive B-cell chronic lymphocytic leukemia who have had previous first-line inducti on treatment with MabThera (RCC regimen).After 6 months of induction therapy wit h RCC (MabThera + cladribine + cyclophosphamide) patients will be randomized eit her to receive maintenance treatment with MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The anticipated time on study trea tment is 2+ years, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphocytic Leukemia, Chronic
  • Drug: cladribine
    0.12mg/kg iv on days 2-4 of each cycle (induction phase)
  • Drug: cyclophosphamide
    250mg/m2 iv on days 2-4 (induction phase)
  • Drug: rituximab [MabThera/Rituxan]
    375mg/m2 on day 1 of cycle 1 (induction phase)
  • Drug: rituximab [MabThera/Rituxan]
    500mg/m2 iv on day 1 of cycles 2-6 (induction phase)
  • Drug: rituximab [MabThera/Rituxan]
    375mg/m2 iv every 12 weeks (maintenance phase)
  • Experimental: 1
    Interventions:
    • Drug: cladribine
    • Drug: cyclophosphamide
    • Drug: rituximab [MabThera/Rituxan]
    • Drug: rituximab [MabThera/Rituxan]
    • Drug: rituximab [MabThera/Rituxan]
  • Active Comparator: 2
    Interventions:
    • Drug: cladribine
    • Drug: cyclophosphamide
    • Drug: rituximab [MabThera/Rituxan]
    • Drug: rituximab [MabThera/Rituxan]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
128
July 2017
July 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • confirmed diagnosis of B-cell chronic lymphocytic leukemia;
  • stage I-IV disease with evidence of progression;
  • no previous chemotherapy, radiotherapy or immunotherapy for B-cell chronic lymphocytic leukemia;
  • ECOG PS 0-2.

Exclusion Criteria:

  • active secondary malignancy or transformation to aggressive lymphoma;
  • medical condition requiring chronic use of oral corticosteroids at a dose of 1mg/kg or 60 mg/m2 over 2 weeks;
  • prior treatment with interferon, MabThera or another monoclonal antibody, immunosuppressive treatment or radiotherapy for 12 months before study start;
  • history of other malignancies within 2 years before study entry, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belarus,   Poland
 
NCT00718549
ML21283, 2008-001140-39
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP