EUCTR2005-005074-69-GB
Active, not recruiting
Phase 1
Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH, MabCampath) in Patients with Previously Treated B Cell Chronic Lymphocytic Leukemia
DrugsCAMPATH/MabCampath
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Genzyme Europe BV
- Enrollment
- 85
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) A diagnosis of B\-CLL; according to the NCIWG Criteria (Appendix D)
- •(2\) At least 18 years old
- •(3\) World Health Organization (WHO) performance status of 0, 1, or 2
- •(4\) Life expectancy \=12 weeks
- •(5\) Previous therapy with at least one but no more than five regimens (single agent or combination regimen). One regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting \>3 months.
- •(6\) Patient requires treatment for chronic lymphocytic leukemia (CLL) per the following criteria
- •\* Rai stage III or IV (Appendix D).
- •\* Rai stage 0\-II with at least one of the following:
- •\- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
- •\- Massive (i.e., \>6 cm below the left costal margin) or progressive splenomegaly
Exclusion Criteria
- •(1\) Positive Coombs test and evidence of active hemolysis
- •(2\) Platelet count \<50 ×109/L without splenomegaly
- •(3\) History of anaphylaxis following exposure to rat or mouse derived CDR grafted humanized monoclonal antibodies
- •(4\) Previously treated with CAMPATH
- •(5\) Previous bone marrow transplant
- •(6\) Known central nervous system (CNS) involvement with B\-CLL
- •(7\) Active infection, including human immunodeficiency virus (HIV) positive
- •(8\) Active secondary malignancy
- •(9\) Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti\-tuberculous medication (e.g., isoniazid, rifampin, streptomycin, pyrazinamide, or others)
- •(10\) Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb) test with a documented history of prior hepatitis B immunization are eligible as long as other criteria are met (ie, negative tests for: hepatitis B surface antigen \[HBsAg], hepatitis B core antibody \[HBcAb] and hepatitis C virus antibody \[HCVAb]).
Outcomes
Primary Outcomes
Not specified
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