Status:
COMPLETED
Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Berlex Laboratories, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if giving CAMPATH-1H first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patient...
Detailed Description
The purposes of this trial are: 1. To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion followed by subcutaneous injection in patients with previously treated CLL who have...
Eligibility Criteria
Inclusion
- Age \>= 18 years (CLL does not occur in the pediatric population).
- Signed informed consent.
- World Health Organization (WHO) performance status of 0, 1, or 2.
- Patients with B-CLL who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. Patients previously treated with Campath-1H are eligible.
- Serum creatinine \<= 2mg/dL, total bilirubin \<= 2mg/dL, and SGPT \<= 3x upper limit of normal (ULN) unless due to direct infiltration of the liver or kidney with malignant cells.
Exclusion
- Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
- Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal antibodies for at least 4 weeks prior to study start.
- Pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception.
- Patients with history of HIV positivity.
- Active secondary malignancy.
- Active uncontrolled infection or any major systemic or other illness that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety or interfere with the interpretation of study results.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00102661
Start Date
October 1 2002
End Date
September 1 2006
Last Update
July 31 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030