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Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease

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: NCT00462189
Recruitment Status : Unknown
Verified April 2007 by Cambridge Antibody Technology.
Recruitment status was:  Recruiting
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
Information provided by:
Cambridge Antibody Technology

Brief Summary:

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded to chemotherapy, surgery or radiation therapy.

PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have hairy cell leukemia (HCL) that has not responded to treatment.

Condition or disease Intervention/treatment Phase
Leukemia Hairy Cell Leukemia HCL Drug: Immunotoxin therapy Drug: CAT-8015 Immunotoxin Procedure: Biological therapy Phase 1

Detailed Description:

OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, complete response or disease progression. Patients are followed at 1, 3, 6,12,15,18, 21, 24 months following the start of the last treatment cycle.

Cohorts of 3-6 patients each will receive escalating doses of recombinant CAT-8015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, between16 to 25 new patients will be added to the MTD cohort depending on how well the CAT-8015 is tolerated.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patient With Relapsed or Refractory Hairy Cell Leukemia (HCL)
Study Start Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Primary Outcome Measures :
  1. Estimate the maximum dose that can be safely administered to a patient
  2. Characterize the toxicity profile of CAT-8015
  3. Study the clinical pharmacology of CAT-8015
  4. Observe anti-tumor activity, if any.

Secondary Outcome Measures :
  1. To assess the immunogenic potential of CAT-8015 to induce antibodies
  2. To investigate the potential of biomarkers to predict any therapeutic or toxic response.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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



  • Confirmed diagnosis of hairy cell leukemia
  • Measurable disease

At least one of the following indications for treatment:

  • Neutropenia (ANC <1000 cells/µL)
  • Anemia (Hgb <10g/dL)
  • Thrombocytopenia (Plt <100,000/µL)
  • An absolute lymphocyte count of >20,000 cells/µL, or
  • Symptomatic splenomegaly
  • Patient's must have had at least 2 prior systemic therapies. There must have been at least 2 prior courses of purine analog, or 1 if the response to this course lasted <2 years, or if the patient had unacceptable toxicity to purine analog.


Performance status • ECOG 0-2

Life expectancy

• Life expectancy of greater than 6 months, as assessed by the principal investigator


  • Patients with other cancers who meet eligibility criteria and have had less than 5 years of disease free survival will be considered on a case-by-case basis
  • Ability to understand and sign informed consent
  • Female and male patients agree to use an approved method of contraception during the study


  • Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)
  • History of bone marrow transplant
  • Pregnant or breast-feeding females
  • Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.
  • HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
  • Hepatitis B surface antigen positive
  • Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements

Hepatic function: serum transaminases (either ALT or AST) or bilirubin:

• ≥ Grade 2, unless bilirubin is due to Gilbert's disease

Renal function: serum creatinine clearance ≤60mL/min as estimated by Cockroft-Gault formula

Hematologic function:

  • The ANC <1000/cmm, or platelet count <50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy)
  • Baseline coagulopathy > grade 3 unless due to anticoagulant therapy
  • A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies

Pulmonary function:

• Patients with < 50% of predicted forced expiratory volume (FEV1) or <50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed following bronchodilator therapy.

Recent prior therapy:

  • Cytotoxic chemotherapy (except stable doses of prednisone), whole body electron beam radiation therapy, interferon, retinoids or other systemic therapy, or investigational therapy of the malignancy for 3 weeks prior to entry into the trial
  • Less than or equal to < 3 months prior monoclonal antibody therapy (i.e. rituximab)
  • Patients who have received or are receiving radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port
  • Any history of pseudomonas-exotoxin (PE) immunotoxin administration

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): NCT00462189

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United States, California
Stanford University School of Medicine Not yet recruiting
Stanford, California, United States, 94305
Contact: Sylvia Quesada, RN    650-725-4041      
Principal Investigator: Steven E Coutre, MD         
United States, Illinois
Cancer Center of Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Simbi Acharya    312-695-1383      
Principal Investigator: Martin Tallman, MD         
United States, Maryland
Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892
Contact: NCI Clinical Trials Referral    888-624-1937      
Principal Investigator: Robert J Kreitman, MD         
Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz) Not yet recruiting
Lodz, Poland
Contact: Krzysztof Jamroziak, MD    (48) 42 689-5191      
Principal Investigator: Tadeusz Robak, Professor         
United Kingdom
Royal Marsden Hospital and Institute of Cancer Research Not yet recruiting
Surrey, United Kingdom
Contact: Claire Dearden, MD    (44) 20 7352 8171      
Principal Investigator: Claire Dearden, MD         
Sponsors and Collaborators
Cambridge Antibody Technology
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00462189    
Other Study ID Numbers: CAT-8015-1001
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007
Keywords provided by Cambridge Antibody Technology:
Additional relevant MeSH terms:
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Leukemia, Hairy Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunotoxin HA22
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents