LymphomaPhase 1NCT00587015
A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Non-Hodgkin's Lymphoma (NHL)
A Phase 1 study testing CAT-8015 in people with Lymphoma, run by MedImmune LLC at 3 sites in 2 countries.
Trial summary
A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be safely administered to a patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- CAT-8015
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2007to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible to participate in the study:
- 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 regimen.
- ECOG performance status of 0-2
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- 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
Who cannot join
- Subjects meeting any of the following criteria are not eligible for participation in 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
- HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
- Hepatitis B surface antigen positive
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- 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 therapy.
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
NCI, National Institutes of Health
Bethesda, Maryland, 20892
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211-1850
About this study
Official title: A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be safely administered to a patient.
Read the detailed description
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.
- Conditions
- Lymphoma
- Being tested
- CAT-8015
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT-8015Drug
The dose level of the initial cohort will be 5 μg/kg so cohorts will be dosed at 5, 10, 20, 30, 40, 50, 60…μg/kg until toxicity supervenes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CAT-8015 Receives: Drug: CAT-8015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD.
Measured: Day 28
Secondary outcomes (1)
Assess immunogenicity of CAT 8015 and potential biomarkers for therapeutic or toxicity responses.
Measured: Day 0-7; 0-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionOct 2009
Why it stopped: Due to a lack of IP supply and then terminated because they were combined into one new study with the new IP formulation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Leechleider, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587015
- Sponsor's protocol ID
- CAT-8015-1003
- Status last verified
- Nov 2011
- First submitted
- 21 Dec 2007
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT00587015
- Acronym / sponsor ID
- CAT-8015-1003
- Conditions
- Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a lack of IP supply and then terminated because they were combined into one new study with the new IP formulation.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be safely administered to a patient.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CAT-8015CAT-8015 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following criteria to be eligible to participate in the study:
- 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 regimen.
Key exclusion criteria (23 listed)
- Subjects meeting any of the following criteria are not eligible for participation in 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
- HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAT-8015The dose level of the initial cohort will be 5 μg/kg so cohorts will be dosed at 5, 10, 20, 30, 40, 50, 60…μg/kg until toxicity supervenes. | Drug | 1 |
Primary outcome
Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD.
Time frame: Day 28
1 secondary outcome
Assess immunogenicity of CAT 8015 and potential biomarkers for therapeutic or toxicity responses.
Time frame: Day 0-7; 0-14
Results and safety
The study was stopped early (reason given: Due to a lack of IP supply and then terminated because they were combined into one new study with the new IP formulation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Leechleider, M.D. study director
MedImmune LLC
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAT-8015 in people with Lymphoma, run by MedImmune LLC at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to a lack of IP supply and then terminated because they were combined into one new study with the new IP formulation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.