EUCTR2005-005074-69-CZ
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
- 4 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 5 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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