A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858117
Recruitment Status : Active, not recruiting
First Posted : March 9, 2009
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Northwestern University

March 6, 2009
March 9, 2009
February 6, 2018
March 2005
December 2018   (Final data collection date for primary outcome measure)
  • To determine the response rate to the study medications, Alemtuzumab and Rituximab [ Time Frame: At 9 weeks (during therapy), 18 weeks (at the completion of therapy), and 30 weeks ]
    Response rate to the study medications, Alemtuzumab and Rituximab, will be measured at 9 weeks, 18 weeks, and 30 weeks, by physical examination and evaluation of peripheral blood and bone marrow through lab tests.
  • Collect data on the toxicity of the study medications, Alemtuzumab and Rituximab [ Time Frame: Every 2 weeks while on treatment and then monthly for 6 months, then every 3 months for 4.5 years (54 months) ]
    Toxicity data of the study medications, Alemtuzumab and Rituximab will be evaluated by blood tests every 2 weeks while on treatment and then monthly for 6 months, then every 3 months for 4.5 years (54 months)
  • Response rate
  • Toxicity as assessed by NCI CTCAE v3.0
Complete list of historical versions of study NCT00858117 on Archive Site
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A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL

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.


  • To determine the response rate in patients with previously untreated B-cell chronic lymphocytic leukemia treated with alemtuzumab and rituximab.
  • To evaluate the toxicity of alemtuzumab and rituximab in these patients.

OUTLINE: Patients receive alemtuzumab subcutaneously on days 1, 3, and 5 in weeks 1-18 and rituximab IV on day 1 in weeks 3, 5, 7, 9, 11, 13, 15, and 17 in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples are collected periodically for laboratory biomarker studies. Samples are analyzed for surface markers (e.g., CD3, CD4, CD8, CD10, CD19, CD20, CD25, CD38, CD52, Zap-70) and IgVH by PCR, flow cytometry, and FISH. Samples are also analyzed for alemtuzumab and anti-alemtuzumab antibody levels by flow cytometry.

After completion of study treatment, patients are followed periodically for 5 years.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Biological: Alemtuzumab
    Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks
    Other Name: Campath-1H
  • Biological: Rituximab
    Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks
    Other Name: Rituxan
Experimental: Alemtuzumab and Rituximab
Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.
  • Biological: Alemtuzumab
  • Biological: Rituximab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2019
December 2018   (Final data collection date for primary outcome measure)


  • 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 < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts
    • Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the following:

      • Predominant population of cells share B-cell antigens with CD-5 in the absence of other pan-T-cell markers (e.g., CD-3, CD-2)
      • B-cell expresses either lambda or kappa light chains
      • Surface immunoglobulin with low-cell surface density expression NOTE: *Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
  • Requires therapy, as indicated by ≥ 1 of the following criteria:

    • Unintentional weight loss > 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 < 10 g/dL) and/or thrombocytopenia (platelet count < 100,000/mm³)
    • Massive (i.e., > 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 < 6 months
  • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility


  • ECOG performance status 0-2
  • ANC ≥ 1,000/mm³*
  • Platelet count ≥ 50,000/mm³*
  • Hemoglobin ≥ 10 g/dL*
  • Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance > 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 corticosteroid therapy allowed
  • No prior cytotoxic therapy (other than corticosteroids)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NU 04H6
NU 04H6 ( Other Identifier: Northwestern University )
STU00004494 ( Other Identifier: Northwestern University IRB )
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Northwestern University
Northwestern University
Principal Investigator: Olga Frankfurt, MD Northwestern University
Northwestern University
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP