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Apolizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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: NCT00089154
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : July 16, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

Condition or disease Intervention/treatment Phase
Noncontiguous Stage II Small Lymphocytic Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Stage III Small Lymphocytic Lymphoma Stage IV Small Lymphocytic Lymphoma Biological: apolizumab Other: laboratory biomarker analysis Other: pharmacological study Phase 2

Detailed Description:


I. Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III or IV small lymphocytic lymphoma treated with apolizumab.

II. Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients.


I. Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed.

III. To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy.

IV. To determine the cellular properties which convey resistance to apolizumab in CLL in vivo.

OUTLINE: This is a multicenter study.

Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then every 6 months for 3 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol
Study Start Date : August 2004
Actual Primary Completion Date : October 2005

Arm Intervention/treatment
Experimental: Treatment (apolizumab)
Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity.
Biological: apolizumab
Given IV
Other Names:
  • 1D1O Anti-lymphoma Antibody
  • MOAB 1D10
  • MoAb Hu1D10
  • Monoclonal antibody 1D10
  • Monoclonal Antibody Hu1D10

Other: laboratory biomarker analysis
Correlative studies

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Primary Outcome Measures :
  1. Response rate (CR+PR) [ Time Frame: Up to 3 years ]
  2. Progression-free survival rate [ Time Frame: Up to 3 years ]
  3. Frequency and severity of treatment-related adverse events [ Time Frame: Up to 30 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic clearance [ Time Frame: Days 1, 2, 3, 5, 8, 15, 22, 26, 27, 29 and 1, 2, 3, and 6 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically confirmed hematologic malignancy of 1 of the following histologies:

    • Chronic lymphocytic leukemia (CLL)
    • Small lymphocytic lymphoma (SLL)

      • Noncontiguous stage II or stage III or IV disease
  • Received >= 1 form of prior immunotherapy or chemotherapy

    • Completed therapy at least 4 weeks ago
  • Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria:

    • Progressively worsening disease (symptoms increasing in severity by 1 toxicity criterion over a period of >= 2 weeks)
    • Progressively worsening anemia or thrombocytopenia
    • Progressively worsening lymphadenopathy
    • Massive splenomegaly or hypersplenism
    • Hyperlymphocytosis (WBC > 200,000/mm^3) OR lymphocyte doubling time < 12 months
    • Marrow failure due to marrow infiltration by leukemia or lymphoma
  • Leukemia cells must express 1D10 antigen > 2 times mean fluorescent intensity of the control by flow cytometry of blood or bone marrow cells
  • Performance status - ECOG 0-2
  • At least 2 years
  • Platelet count >= 50,000/mm^3 (transfusion independent)
  • Bilirubin =< 3 mg/dL (unless due to tumor involvement)
  • Creatinine =< 2.0 mg/dL
  • No decompensated congestive heart failure
  • No unstable angina
  • No myocardial infarction within the past 6 months not corrected by surgery or percutaneous transluminal coronary angioplasty
  • No active infection requiring oral or IV antibiotics
  • No other malignancy that limits life expectancy to < 2 years or that requires active anticancer therapy within 4 weeks of study entry
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study treatment
  • Recovered from prior immunotherapy
  • More than 3 months since prior alemtuzumab or rituximab
  • No prior apolizumab
  • Recovered from prior chemotherapy
  • More than 4 weeks since prior anticancer hormonal therapy
  • More than 4 weeks since prior anticancer radiotherapy
  • More than 4 weeks since prior anticancer surgery
  • At least 4 weeks since other prior therapy for CLL or SLL and recovered

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): NCT00089154

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United States, California
Chronic Lymphocytic Leukemia Research Consortium (CRC)
La Jolla, California, United States, 92093-0820
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: John Byrd Ohio State University

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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00089154     History of Changes
Other Study ID Numbers: NCI-2012-01454
OSU 0410
R21CA091564 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2004    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents