Phase 3
Completed N=128
A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)
Lymphocytic Leukemia, Chronic
Source: ClinicalTrials.gov NCT00718549 ↗
Enrolled (actual)
128
Serious AEs
35.2%
Results posted
Aug 2018
Primary outcomePrimary: 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) — 27.3; 54.5; 40.9 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
27.3; 54.5; 40.9 | — |
| PRIMARY Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL |
NA; 2.1; 3.1 | 0.028 sig |
| SECONDARY Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL |
73.2; 90.5; 72.2; 82.1 | 0.155 |
| SECONDARY Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR |
15.4; 28.6; 20.0; 25.0 | 0.634 |
| SECONDARY PFS Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors |
3.0; 4.0; 4.0; 3.0; 3.1; 3.0 | 0.752 |
| SECONDARY 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 |
73.3; 73.0; 80.6; 69.7; 77.5; 61.5 | 0.969 |
| SECONDARY 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 |
80.8; 84.6; 85.7; 80.0; 80.6; 87.5 | 0.768 |
| SECONDARY Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 29 |
87.8; 79.2; 87.5; 82.9; 80.4; 100.0 | 0.357 |
| SECONDARY Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 129 |
72.2; 83.3; 71.4; 76.5; 75.0; 75.0 | 0.591 |
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
Data sourced from ClinicalTrials.gov (NCT00718549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.