A Phase I,Multicenter, Dose Escalation Study of CAT-8015 in Patients With Chronic Leukemia
This study has suspended participant recruitment.
(On hold due to lack of CTM supply)
Cambridge Antibody Technology
Information provided by (Responsible Party):
First received: December 21, 2007
Last updated: January 3, 2012
Last verified: January 2012
To demonstrate the safety of CAT-8015 at MTD dose.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I, Multicenter, Dose-Escalation Study of CAT-8015 in Patients With Relapsed or Refactory Chronic Lymphocytic Leukemia (CLL) Prolymphocytic Leukemia (PLL) or, Small Lymphocytic Leukemia (SLL)
Primary Outcome Measures:
- Assess safety, efficacy,characterize toxicity profile, study pharmacology, observe anti-tumor activity [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess immunogenicity and potential biomarkers for response or toxicity for phase 2 dose [ Time Frame: Days 0-7; 0-14 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||January 2010 (Final data collection date for primary outcome measure)
Active Comparator: 1
Maximum Tolerated Dose
To demonstrate the safety of CAT-8015 at the MTD, defined as the highest dose that can be safely administered to patients, and to establish a recommended Phase 2 dose.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Confirmed diagnosis of B-Cell Leukemia (CLL, PLL, or SLL)
- Measurable Disease
- Disease characteristics: Patients with chronic lymphocytic leukemia (CLL) or Small Lymphocytic Leukemia (SLL) are eligible if they have failed 2 or more prior courses of standard chemo and/or biologic therapy (e.g. Rituxan)_ and prolymphocytic leukemia (PLL) will be eligible if they have failed at least one prior standard chemotherapeutic regimen. Medical indications for treatment include progressive disease-related symptoms, progressive cytopenias due to marrow involvement, progressive or painful splenomegaly or adenopathy, rapidly increasing lymphocytosis, autoimmune hemolytic anemia or thrombocytopenia and increased frequency of infections.
- ECOG performance status of 0-2
- Patients with other cancers who meet eligibility criteria and have had less than 5 yrs. of disease-free survival will be considered on a case-by-case basis
- Life expectancy of greater than 6 mos., as assessed by the principal investigator
- Must be able to understand and sign the informed consent
- Must be at least 18 years old
- Female and Male patients agree to use an approved method of contraception during the study
- 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
- Patients who 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 direct bilirubin greater than or equal to Grade 2, unless bilirubin is due to Gilbert's disease
- Renal function: Serum creatinine clearance is less than or equal to 60 mL/min as estimated by Cockcroft-Gault formula
- The ANC less than 1000/cmm, or platelet count less than 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 greater than or equal to 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 therapy
- Patients with less than 50% of predicted forced expiratory volume (FEV-1) or less than 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 three wks. prior to entry into the trial.
- Less than or equal to 1 mos. 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 not be excluded providing the volume of the bone marrow treated is less than 10% and also the patient has measureable disease outside the radiation port.
- Any history of prior pseudomonas - exotoxin immunotoxin administrator
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587457
|Tower Hematology Oncology Medical Group
|Beverly Hills, California, United States, 90211-1850 |
|Indiana Univ. Cancer Center
|Indianapolis, Indiana, United States, 46202 |
|Indianapolis, Indiana, United States |
|Bethesda, Maryland, United States, 20892 |
|Klinika Hermatologii Uniwersytetu
|Lodz, Poland, 93-510 |
|Lodz, Poland |
Cambridge Antibody Technology
||Ramy Ibrahim, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 21, 2007
||January 3, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Leukemia, Lymphocytic, Chronic, B-Cell
Immune System Diseases
Neoplasms by Histologic Type