Phase 2
N=60
Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Leukemia, Lymphocytic, Chronic, B-Cell
Bottom Line
View on ClinicalTrials.gov: NCT00206726 ↗Enrolled (actual)
60
Serious AEs
71.9%
Results posted
Jan 2011
Primary outcome: Primary: Complete Response (CR) — 8.3 Percentage of participants with CR — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alemtuzumab plus Fludarabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genzyme, a Sanofi Company
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) |
8.3 | 0.014 sig |
| SECONDARY Overall Response (OR) |
28.3 | — |
| SECONDARY Overall Survival (OS) |
86.4 | — |
| SECONDARY Progression-free Survival (PFS) |
48.8 | — |
| SECONDARY Percentage of Participants With Overall Response at Different Observation Times |
76.5; 64.7; 29.4 | — |
| SECONDARY Number of Participants With Minimal Residual Disease (MRD) |
3; 2; 0 | — |
Summary
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy.
Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.
Eligibility Criteria
Inclusion Criteria
- Patient must have confirmed B-CLL.
- Patients must have received at least one prior therapy and must require treatment for active disease
Exclusion Criteria
- Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study.
- History of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy
- History of human immunodeficiency virus (HIV) positivity.
- Active infection requiring treatment
- Pregnancy or lactation
- Other severe, concurrent diseases or mental disorders
- Central nervous system involvement of chronic lymphocytic leukemia (CLL)
Data sourced from ClinicalTrials.gov (NCT00206726). 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.