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Monoclonal Antibodies

Alemtuzumab + Chemotherapy for Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Toronto Sunnybrook Regional Cancer Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed, CD52+ disease
Measurable or evaluable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying alemtuzumab and combination chemotherapy as an initial treatment for patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

Who is the study for?
This trial is for adults with newly diagnosed aggressive T-cell non-Hodgkin's lymphoma stages II-IV. They must have a certain level of physical fitness, life expectancy over 4 months, and their cancer cells should be CD52+. Key blood counts and organ functions need to be within specific ranges. Pregnant or nursing individuals can't participate, nor those with HIV, other immunodeficiencies, or recent malignancies.Check my eligibility
What is being tested?
The trial tests the combination of alemtuzumab (a monoclonal antibody) with chemotherapy drugs cyclophosphamide, doxorubicin, vincristine, and prednisone in patients who haven't had previous treatments. It aims to find the best dose of alemtuzumab that's effective while monitoring side effects.See study design
What are the potential side effects?
Potential side effects include reactions where alemtuzumab is infused into the body; impact on blood cell counts leading to increased infection risk; fatigue; nausea; liver function changes; and potential harm to organs from inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disease is newly diagnosed and CD52 positive.
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My cancer can be measured or seen on tests.
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My condition is at stage II-IV.
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I can take care of myself and perform daily activities.
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My lymphoma is a type of aggressive T-cell non-Hodgkin's.

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
Dose-limiting toxicities
Pharmacokinetics of alemtuzumab
Safety
+1 more
Secondary outcome measures
Effects of treatment on T- and B-cell reconstitution by flow cytometry at baseline and at 3, 6, and 12 months
Efficacy as assessed by clinical, radiologic, pathologic, and laboratory measurements
Overall response rate
+2 more

Find a Location

Who is running the clinical trial?

Toronto Sunnybrook Regional Cancer CentreLead Sponsor
9 Previous Clinical Trials
869 Total Patients Enrolled
Rena Buckstein, MDStudy ChairToronto Sunnybrook Regional Cancer Centre
3 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Lymphoma
20 Patients Enrolled for Lymphoma

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00363090 — Phase 1 & 2
Lymphoma Research Study Groups:
Lymphoma Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT00363090 — Phase 1 & 2
Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00363090 — Phase 1 & 2

Frequently Asked Questions

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

At how many hospitals is this particular clinical trial being conducted?

"Currently, there are 5 clinical trial sites enrolling patients for this study. The locations of the centres are in Hamilton, London, Vancouver and a few other cities. If you choose to enroll in the trial, try to select the location nearest you to cut down on travel time."

Answered by AI

Does this research project have room for more test subjects?

"No, this particular trial is not recruiting patients at the moment. Although, it is worth noting that there are 1,760 other trials actively looking for participants on clinicaltrials.gov. This specific study was first posted September 1st, 2006 and edited last on September 19th, 2013."

Answered by AI
~5 spots leftby Mar 2025