Status:
UNKNOWN
Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy
Lead Sponsor:
Chronic Lymphocytic Leukemia Research Consortium
Collaborating Sponsors:
Bayer
Conditions:
B-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieve...
Detailed Description
Approximately 95% of cases involve the clonal proliferation of B cells. Paraproteins, often of the IgM class, can be detected in the serum and/or urine of most patients with CLL. Unique cell surface m...
Eligibility Criteria
Inclusion
- Male or female, at least 18 years old.
- Signed informed consent.
- Zubrod performance status of 0, 1, or 2 (Appendix C).
- Patients with CLL, CLL/PLL or PLL (prolymphocytic) who have achieved a clinical complete remission by NCI-WG criteria with chemotherapy, eg., alkylating agents, fludarabine or chemoimmunotherapy but have documentation of residual disease by immunophenotyping showing: (a) a residual population of CD5 and CD19 positive cells that comprise ≥ 10% of the marrow mononuclear cell population; or (b) a residual population of CD5 and CD19 positive cells that comprise \<10% of the marrow mononuclear cells and have a Kappa/Lambda ratio \>6 or \<.33.
- Patients with CLL who have achieved a partial remission (PR) or nodular partial remission (nPR) by NCI-WG criteria after chemotherapy.
- Creatinine, bilirubin, AST or ALT and alkaline phosphatase ≤2 x the upper limit of normal.
Exclusion
- Active infection.
- Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
- Less than 2 months since prior chemotherapy.
- Previous treatment with CAMPATH-1H.
- Pregnant or nursing women.
- Patients on corticosteroids.
- Uncontrolled autoimmune hemolytic anemia.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00800943
Start Date
December 1 2003
End Date
August 1 2010
Last Update
December 3 2008
Active Locations (3)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009