Status:
COMPLETED
Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether the combination of alemtuzumab and rituximab is safe and effective in treating patients with relapsed Chronic Lymphocytic Leukemia (CLL) and to determ...
Detailed Description
This study proposes to combine alemtuzumab, which effectively treats peripheral blood and bone marrow disease in CLL, with rituximab, which has activity in lymph node disease, in a streamlined and con...
Eligibility Criteria
Inclusion
- Subjects must be diagnosed with B-CLL / SLL (B-chronic lymphocytic leukemia / small lymphocytic lymphoma) based on the standard histologic and immunophenotypic criteria described in the WHO classification of lymphoid malignancies, including immunophenotypic confirmation that the tumor cells co-express B cell antigens CD19 / 20 and CD5. Mantle cell lymphoma should be excluded based on positive staining of the tumor cells for CD23, or the absence of staining of the tumor cells for cyclin D1 or the absence of t(11;14).
- The above diagnosis must be confirmed at Brigham \& Women's Hospital or Dana-Farber Cancer Institute.
- Subjects must have relapsed after at least one prior fludarabine-containing regimen and require treatment based on NCI-WG criteria (Appendix A).
- Subjects must have measurable disease (lymphocytosis \> 5,000 / ml, or palpable lymphadenopathy or CT measurable lymphadenopathy \> 1.5 cm, or bone marrow involvement \>30%).
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- Age \>= 18
- WHO Performance status \<= 2
- Subject has provided written informed consent.
- Expected survival \> 3 months
Exclusion
- History of HIV
- Active infection uncontrolled by appropriate antibacterial, antiviral or antifungal therapy
- Known CNS involvement with CLL
- Pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women
- Prior anti-neoplastic therapy within the last three weeks
- Patients will NOT be excluded because they have received prior rituximab or alemtuzumab
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00330252
Start Date
May 1 2006
End Date
January 1 2014
Last Update
May 13 2016
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215