Phase 2
N=102
Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
B-cell Chronic Lymphocytic Leukemia · Stage I Chronic Lymphocytic Leukemia · Stage II Chronic Lymphocytic Leukemia · Stage III Chronic Lymphocytic Leukemia · Stage IV Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00098670 ↗Enrolled (actual)
102
Serious AEs
26.3%
Results posted
Dec 2012
Primary outcome: Primary: Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab — 38 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alemtuzumab (Biological); rituximab (Biological); fludarabine phosphate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab |
38 | — |
| SECONDARY Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab |
92 | — |
| SECONDARY 2 Year Progression Free Survival |
72 | — |
| SECONDARY 2 Year Survival |
86 | — |
| SECONDARY Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab |
23 | — |
Summary
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.
Eligibility Criteria
Inclusion Criteria
- Specific Diagnosis of B-Cell CLL
- An absolute lymphocytosis of > 5,000/μL
- Morphologically, the lymphocytes must appear mature with 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; the overall cellularity must be normocellular or hypercellular
- Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression
- Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV)
- Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
- Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;
- Presence of weight loss > 10% over the preceding 6 month period;
- Grade 2 or 3 fatigue;
- Fevers > 100.5°F or night sweats for greater than 2 weeks without evidence of infection;
- Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months
- No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL
- No medical condition requiring chronic use of oral corticosteroids
- Performance Status 0 - 2
- Due to alterations in host immunity, patients with HIV may not be enrolled
- Due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
- Creatinine =< 1.5 x upper limit of institutional normal value
- Coomb's Testing NEGATIVE
Data sourced from ClinicalTrials.gov (NCT00098670). 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.