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A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

Phase 1
18 Years
80 Years
Not Enrolling

Thank you

Trial Information

A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

To estimate the maximum tolerated dose (MTD), defined as the highest dose that can be safely
administered to a patient, and to establish a safe dose, based on MTD, for subsequent
clinical testing.

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible to participate in the

- Confirmed diagnosis of B-cell non-Hodgkin's lymphoma

- Measurable disease

- Evidence of CD22-positive malignancy by the following criteria, > 30% of malignant
cells from a disease site CD22+ by FACS analysis or, > 15% of malignant cells from a
disease site must react with anti-CD22 by immunohistochemistry

- Disease characteristics: Patients with indolent subtypes of CD22+ B-cell non-
Hodgkin's lymphoma, including, but not limited to mantle cell lymphoma, follicular
lymphoma and Waldenström's macroglobulinemia, are eligible if stage III-IV. if stage
III-IV. Patients must have failed at least two or more courses of prior standard
chemotherapy and/or biologic therapy (e.g. Rituxan). Patients with progressive mantle
cell lymphoma may be eligible if they have failed one prior standard therapeutic

- ECOG performance status of 0-2

- Patients with other cancers who meet eligibility criteria and have less than 5 years
of disease free survival will be considered on a case-by-case basis

- Life expectancy of less than 6 months, as assessed by the principal investigator

- Must be able to understand and sign informed consent

- Must be at least 18 years old

- Female and male patients must agree to use an approved method of contraception during
the study

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for participation in the

- History of allogeneic bone marrow transplant

- Documented and ongoing central nervous system involvement with their malignant
disease (history of CNS involvement is not an exclusion criterion)

- Pregnant or breast-feeding females

- 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

- 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.

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).

- 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

- Baseline coagulopathy greater than or equal to Grade 3 unless due to anticoagulant

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 after bronchodilator therapy.

Recent prior therapy:

- Cytotoxic chemotherapy, corticosteroids (except stable doses of prednisone), whole
body electron beam radiation therapy, hormonal, biologic or other standard or any
investigational therapy of the malignancy for 3 weeks prior to entry into the trial

- Less than or equal to 1 month prior monoclonal antibody therapy (i.e. rituximab)

- Patients who are receiving or have received 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 prior pseudomonas-exotoxin immunotoxin (PE) administration.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD.

Outcome Time Frame:

Day 28

Safety Issue:


Principal Investigator

Robert Leechleider, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

October 2009

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Tower Hematology Oncology Medical Group Los Angeles, California  90048
NCI, National Institutes of Health Bethesda, Maryland  20892