Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)

• Status: Terminated
• Trial end date: 2019-02-13
• Target enrollment: 0
• Participant gender: All

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 drug combination will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Cyclacel Pharmaceuticals, Inc.; National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Rituximab; Sapacitabine

Criteria

Inclusion Criteria:

1. Patients must have a diagnosis of CLL/SLL and be previously treated

2. Patients must have had Fluorescence in situ Hybridization (FISH) evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23

3. Patients must have an indication for treatment by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria

4. Age >/= 18 years

5. Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status

6. Adequate renal and hepatic function as indicated by all the following: serum creatinineof normal; AND total bilirubin

7. 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

8. Patients must give written informed consent

9. 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 Criteria:

1. Pregnant or breast-feeding females

2. Significant co-morbidity indicated by major organ system dysfunction

3. Active infection, uncontrolled with intravenous antibiotics

4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)

5. 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