Phase 2
Completed N=97
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
Lymphocytic Leukemia, Chronic
Source: ClinicalTrials.gov NCT00738374 ↗
Enrolled (actual)
97
Serious AEs
15.3%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment — 82.4 percentage of participants — p=0.0008
Summary
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment |
82.4 | 0.0008 sig |
| SECONDARY Percentage of Participants With Documented CR, CRi, or PR at the End of Study |
55.9; 34.4 | 0.0795 |
| SECONDARY Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment |
16.5; 2.4; 60.0; 4.7; 3.5; 0.0 | — |
| SECONDARY Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study |
32.3; 21.4; 29.0; 14.3; 3.2; 7.1 | — |
| SECONDARY Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment |
2; 3; 0; 0 | — |
| SECONDARY Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study |
29.4; 18.7; 0.0; 0.0; 26.4; 12.5 | — |
| SECONDARY Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study |
10.0; 30.0 | — |
| SECONDARY Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study |
100.0; 33.3 | — |
| SECONDARY Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment |
43 | — |
| SECONDARY EFS |
1051 | — |
| SECONDARY Number of Participants With Disease Progression or Death |
35 | — |
| SECONDARY PFS |
1059 | — |
| SECONDARY Number of Participants With New CLL Treatment or Death |
22 | — |
| SECONDARY Time to Next Treatment (TTNT) |
1048.19 | — |
| SECONDARY Number of Participants Who Died |
8 | — |
| SECONDARY OS |
1135.04 | — |
| SECONDARY Number of Participants With PD or Death After a Confirmed CR, CRi, or PR |
11; 15 | — |
| SECONDARY Duration of Response |
840.87; 747.82 | 0.2712 |
| SECONDARY Number of Participants With PD or Death After a Confirmed CR/CRi |
2; 8 | — |
| SECONDARY Disease-Free Survival |
699.91; 732.28 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=60 years of age;
- CD20+ chronic lymphocytic leukemia (CLL);
- no previous treatment for CLL;
- ECOG performance status 0-1.
Exclusion Criteria
- co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
- history of severe cardiac disease;
- transformation to aggressive B-cell malignancy.
Data sourced from ClinicalTrials.gov (NCT00738374). 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.