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

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: Alemtuzumab Biological: Rituximab Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL
Study Start Date : March 2005
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. 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.

  2. 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)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00858117

United States, Illinois
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Olga Frankfurt, MD Northwestern University

Responsible Party: Northwestern University Identifier: NCT00858117     History of Changes
Other Study ID Numbers: NU 04H6
NU 04H6 ( Other Identifier: Northwestern University )
STU00004494 ( Other Identifier: Northwestern University IRB )
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents