Phase 3 N=128 Randomized Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT00718549 ↗

Enrolled (actual)

128

Serious AEs

35.2%

Results posted

Aug 2018

Primary outcome: 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 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cladribine (Drug); Cyclophosphamide (Drug); Rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Sep 2015

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

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

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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.