Clinical trial · Interventional
Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)
A Phase II Clinical Trial of Sapacitabine, Cyclophosphamide, and Rituximab (SCR) for Relapsed Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) and Deletion 11q22-23 by FISH
NCT01253460CI-TRIAL-00040434terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual not met
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Sapacitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide, Rituximab + Sapacitabine
- description
- After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Rituximab
- Drug: Sapacitabine
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 84 days
- description
- Patients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least 50% reduction in disease signs and symptoms, a 50% improvement in peripheral blood and greater than or equal to 50% reduction in lymph nodes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \</= 2 6. 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.