Status:
TERMINATED
Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Cyclacel Pharmaceuticals, Inc.
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this dru...
Detailed Description
The Study Drugs: Sapacitabine and cyclophosphamide are designed to damage the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. Rituximab is designed to attach to canc...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of CLL/SLL and be previously treated
- Patients must have had Fluorescence in situ Hybridization (FISH) evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
- Patients must have an indication for treatment by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
- Age \>/= 18 years
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status \</= 2
- Adequate renal and hepatic function as indicated by all the following: serum creatinine \</= 2 mg/dL AND; alanine aminotransferase (ALT) \</= 2.5 times upper limit of normal; AND total bilirubin \</= 2.5 times upper limit of normal
- Patients must have an Absolute neutrophil count (ANC) \>/= 500/uL, Hemoglobin (HGB) \>/= 8 gm/dL, Platelets (PLT) count \>/= 20K/uL, unless attributed to marrow infiltration with CLL
- Patients must give written informed consent
- Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study
Exclusion
- Pregnant or breast-feeding females
- Significant co-morbidity indicated by major organ system dysfunction
- Active infection, uncontrolled with intravenous antibiotics
- Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
- Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (prednisone \>/= 60 mg daily, or equivalent), or immunotherapy within 3 weeks prior to enrollment or concurrent with this trial
Key Trial Info
Start Date :
August 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01253460
Start Date
August 22 2011
End Date
February 13 2019
Last Update
September 6 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030