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Immunotoxin
CAT-8015 Immunotoxin for Leukemia
Phase 1
Waitlist Available
Research Sponsored by Cambridge Antibody Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of B-cell leukemia (CLL, PLL or SLL)
Patients with prolymphocytic leukemia (PLL) will be eligible if they have failed at least one prior standard chemotherapeutic regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will give CAT-8015 immunotoxin to patients with CLL, PLL, or SLL to see if it is an effective treatment against these diseases.
Who is the study for?
This trial is for patients with advanced chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL) who haven't responded to at least two standard treatments. They should be able to perform daily activities with ease or with some limitations, have a life expectancy of over 6 months, and must understand and consent to the study. Pregnant women, those breastfeeding, HIV positive individuals, and people with certain organ dysfunctions are excluded.Check my eligibility
What is being tested?
The trial is testing CAT-8015 immunotoxin's safety and finding the highest dose patients can tolerate without severe side effects. This substance targets cancer cells while sparing normal ones in CLL, PLL, or SLL that's resistant to other therapies.See study design
What are the potential side effects?
While specific side effects aren't listed here, immunotoxins like CAT-8015 may cause symptoms such as allergic reactions during infusion into the bloodstream; they might also affect liver function tests and blood counts due to their targeted action on cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of B-cell leukemia.
Select...
I have PLL and my previous chemotherapy did not work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize the toxicity profile of CAT-8015
Estimate the maximum dose that can be safely administered to a patient
Observe anti-tumor activity, if any
+1 moreSecondary outcome measures
To Investigate the potential of biomarkers to predict any therapeutic or toxic response
To assess the potential of CAT-8015 to induce antibodies
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Who is running the clinical trial?
Cambridge Antibody TechnologyLead Sponsor
7 Previous Clinical Trials
259 Total Patients Enrolled
5 Trials studying Leukemia
245 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses that would affect my study participation.I have CLL or SLL and standard treatments have not worked for me.My lung function tests are below 50% of the predicted values.I have been diagnosed with a type of B-cell leukemia.I have had a bone marrow transplant.I have had another type of cancer but have been disease-free for less than 5 years.My liver tests are abnormal, but it's not due to Gilbert's disease.My kidney function, measured by creatinine clearance, is 60 mL/min or less.I have PLL and my previous chemotherapy did not work.I haven't had cancer treatments like chemotherapy or radiation in the last 3 weeks.My cancer has spread to my brain or spinal cord.I agree to use birth control during the study.My blood has antibodies against CAT-8015 as confirmed by tests.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollees being accepted at this present time for the clinical trial?
"This clinical trial, first posted on March 1st 2007 and last updated April 16th 2007, is not recruiting participants. Nevertheless, there are currently 1411 other trials that require patient recruitment."
Answered by AI
Has this therapy attained authorization from the FDA?
"The safety of this treatment was estimated to be a 1, as Phase 1 trials provide limited data on both efficacy and security."
Answered by AI
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