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Immunotoxin

Immunotoxin for Hairy Cell 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 hairy cell leukemia
Female and male patients agree to use an approved method of contraception during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing an immunotoxin that can kill leukemia cells without harming normal cells. The purpose is to find the maximum tolerated dose in patients who have HCL that hasn't responded to other treatments.

Who is the study for?
This trial is for adults with hairy cell leukemia (HCL) that's not improved after at least two systemic treatments, including purine analogs. They must have certain blood count levels indicating a need for treatment and be in fair health otherwise. Pregnant or breastfeeding individuals, those with significant immune responses to the drug, HIV or hepatitis B, severe organ dysfunction, recent other cancer therapies, or lung function below 50% are excluded.Check my eligibility
What is being tested?
The study tests CAT-8015 immunotoxin's safety and finds the highest dose patients can take without serious side effects. It targets tumor cells while sparing normal ones. Participants will receive escalating doses of CAT-8015 to determine its maximum tolerated dose in those whose HCL hasn't responded to standard treatments.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar drugs often cause reactions where they're injected, general weakness, nausea or vomiting. There may also be liver issues (as indicated by exclusion criteria related to liver function), allergic reactions due to antibodies against the drug components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with hairy cell leukemia.
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I agree to use birth control during the study.
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I am able to get out of my bed or chair and move around.
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I have had another type of cancer but have been disease-free for less than 5 years.
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I have undergone at least 2 systemic therapies for my condition.
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I have low blood counts or a very swollen spleen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Secondary outcome measures
To assess the immunogenic potential of CAT-8015 to induce antibodies
To investigate the potential of biomarkers to predict any therapeutic or toxic response.

Find a Location

Who is running the clinical trial?

Cambridge Antibody TechnologyLead Sponsor
7 Previous Clinical Trials
269 Total Patients Enrolled

Media Library

CAT-8015 Immunotoxin (Immunotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT00462189 — Phase 1
Hairy Cell Leukemia Research Study Groups:

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this clinical trial available to members of the public?

"Currently, this medical trial is not recruiting patients as reported on clinicaltrials.gov; the study was initially posted in April 2007 and last edited a fortnight later. But despite this, 1415 other studies are currently seeking participants."

Answered by AI

What safety measures are taken to protect individuals undergoing this treatment?

"The safety of this experimental treatment is tentatively assessed to be a 1, as it has only been tested in Phase 1 trials with limited data confirming its efficacy and security."

Answered by AI
Recent research and studies
~2 spots leftby Mar 2025