Status:
COMPLETED
Study of AMD3100 (Plerixafor) and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by rituximab, an anti-...
Eligibility Criteria
Inclusion
- Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period or be surgically sterile. Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during treatment and for 3 months after the treatment period or be surgically sterile.
- Diagnosis of CLL or SLL, relapsed from at least one prior therapy.
- CLL/SLL cells expressing CD20 documented during screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Life expectancy of at least 12 weeks.
- Serum creatinine ≤2.0 mg/dL.
- Total bilirubin ≤2.0 mg/dL.
- ALT (alanine aminotransferase) and AST (aspartate aminotransaminase) ≤2 times the upper limit of normal (ULN); for patients with liver involvement of CLL/SLL disease, this limit is increased to ≤5 times the ULN.
- At the time of enrollment, patients must be \>4 weeks since major surgery, radiotherapy, chemotherapy (\>6 weeks for some chemotherapies), immunotherapy, biotherapy/targeted or investigational therapies and recovered from the toxicity of prior treatment to ≤ grade 1.
Exclusion
- White Blood Cells (WBC) \>250 x 10\^9 cells/L.
- Disease refractory to rituximab therapy- defined as a failure to respond to prior rituximab-containing regimen.
- Women who are breastfeeding.
- Active viral hepatitis.
- Active infection or treatment with antimicrobial or antiviral therapy within 1 week of enrollment with the exception of prophylactic therapy.
- History of prior allergic reaction to plerixafor or rituximab.
- Significant lung disease.
- Serious cardiac disease such as a history of sustained ventricular arrhythmia, uncontrolled and serious congestive heart failure (CHF), angina, acute coronary syndrome, or myocardial infarction within 6 months of enrollment or other significant medical or psychosocial conditions that warrants exclusion.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00694590
Start Date
June 1 2008
End Date
September 1 2011
Last Update
March 20 2015
Active Locations (3)
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1
UCSD Moores Cancer Center
La Jolla, California, United States
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
3
UTMD Anderson Cancer Center
Houston, Texas, United States