Safety Study of CAT-8015 Immunotoxin in Patients With CLL, PLL or SLL With Advance Disease

Phase 1

• Conditions: Leukemia

• Registration Number: NCT00457860
• Lead Sponsor: Cambridge Antibody Technology

Brief Summary

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL that has not responded to chemotherapy, surgery or radiation therapy.

PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have chronic lymphocytic leukemia, prolymphocytic leukemia or small lymphocytic lymphoma that has not responded to treatment

Detailed Description

OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, complete response or disease progression. Patients are followed at 1, 3, 6,12,15,18, 21, 24 months following the start of the last treatment cycle.

Cohorts of 3-6 patients each will receive escalating doses of recombinant CAT-8015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, between16 to 25 new patients will be added to the MTD cohort depending on how well the CAT-8015 is tolerated.

Study Timeline

• Study Start: 2007-03
• Status Verified: 2007-04
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-09
• Last Update Submitted: 2007-04-16
• Last Update Posted: 2007-04-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Estimate the maximum dose that can be safely administered to a patient
Study the clinical pharmacology of CAT-8015
Observe anti-tumor activity, if any
Characterize the toxicity profile of CAT-8015

Secondary Outcome Measures

Name	Time	Method
To Investigate the potential of biomarkers to predict any therapeutic or toxic response
To assess the potential of CAT-8015 to induce antibodies

Trial Locations

Locations (4)

Tower Hematology Oncology Medical Group; 🇺🇸 Beverly Hills, California, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States

Klinika Hemtologii Uniwersytetu Medycznego (Medical University of Lodz); 🇵🇱 Lodz, Poland