Phase 2
N=30
A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00858117 ↗Enrolled (actual)
30
Serious AEs
36.7%
Results posted
Oct 2020
Primary outcome: Primary: Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination — 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alemtuzumab (Biological); Rituximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination |
30 | — |
| PRIMARY Number of Patients Treated With Alemtuzumab and Rituximab Combination With Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans |
21 | — |
| SECONDARY Toxicity of the Study Medications, Alemtuzumab and Rituximab |
9; 2; 2; 1; 1; 1 | — |
Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving alemtuzumab together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following criteria:
- Peripheral blood absolute lymphocyte count > 5,000/mm³
- Small- to moderate-size lymphocytes with 10% within the past 6 months
- Extreme fatigue (i.e., ECOG performance status 2)
- Fevers > 100.5°F for 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin 6 cm below left costal margin) or progressive splenomegaly
- Massive nodes/clusters (> 5 cm), progressive symptomatic adenopathy, or adenopathy resulting in end-organ damage
- Progressive lymphocytosis with an increase of > 50% over 2 months or an anticipated doubling time 40 mL/min
- Bilirubin < 2 mg/dL
- AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No active autoimmune anemia or thrombocytopenia
- No active infection requiring oral or intravenous antibiotics
- No second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless curatively treated ≥ 2 years ago NOTE: *If cytopenias are due to degree of bone marrow involvement, patient may be eligible at the discretion of the principal investigator.
PRIOR CONCURRENT THERAPY:
- Prior corticosteroid therapy allowed
- No prior cytotoxic therapy (other than corticosteroids)
Data sourced from ClinicalTrials.gov (NCT00858117). 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.