Phase 2
Completed N=223
HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab
Source: ClinicalTrials.gov NCT00349349 ↗Enrolled (actual)
223
Serious AEs
58.7%
Results posted
Nov 2011
Primary outcomePrimary: Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines — 0; 2; 0; 0 participants — p=<0.0001
Summary
The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines |
0; 2; 0; 0; 0; 1 | <0.0001 sig |
| SECONDARY Duration of Response |
5.5; 6.4; 7.4 | — |
| SECONDARY Progression-Free Survival (PFS) |
4.6; 5.5; 8.9 | — |
| SECONDARY Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment |
8.5; 8.2; 12.1 | — |
| SECONDARY Overall Survival |
13.9; 17.4; 28.3 | — |
| SECONDARY Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts |
-93; -92; -95 | — |
| SECONDARY Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts |
-100; -100; -100 | — |
| SECONDARY Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14) |
-81; -80; -82 | — |
| SECONDARY Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24 |
34; 46; 9 | — |
| SECONDARY Number of Participants With Complete Resolution of Lymphadenopathy |
27; 18; 6 | — |
| SECONDARY Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24 |
25; 35; 7 | — |
| SECONDARY Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening |
64; 89; 14; 27; 19; 1 | — |
| SECONDARY Number of Participants With Improvement in Hemoglobin |
18; 20; 5 | — |
| SECONDARY Number of Participants With Improvement in Thrombocytopenia (Thromb.) |
4; 6 | — |
| SECONDARY Number of Participants With Complete Resolution of Hepatomegaly |
17; 19; 4 | — |
| SECONDARY Number of Participants With Improvement in Neutropenia |
20; 17; 1 | — |
| SECONDARY Number of Participants With Complete Resolution of Splenomegaly |
28; 38; 5 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Event |
90; 107; 16 | — |
| SECONDARY Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24) |
61.4; 549; 1391; 32.1; 827 | — |
| SECONDARY AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24) |
463418; 203536; 171286; 165617 | — |
| SECONDARY Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24) |
326; 277 | — |
| SECONDARY Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24) |
11.7; 12.1 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24) |
4.84; 3.73 | — |
Eligibility Criteria
Inclusion Criteria
- Tumor cell phenotype consistent with B-CLL
- Patients with active B-CLL and with an indication for treatment
- Failing at least one fludarabine-containing treatment regimen
- Failing at least one alemtuzumab-containing treatment regimen
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 4 months
Exclusion Criteria
- Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
- Previous autologous stem cell transplantation within 6 months prior to Visit 2
- Allogeneic stem cell transplantation
- Radioimmunotherapy
Data sourced from ClinicalTrials.gov (NCT00349349). 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.