A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)
Overview
- Phase
- Phase 2
- Intervention
- Chlorambucil
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Cephalon
- Enrollment
- 88
- Locations
- 22
- Primary Endpoint
- Bone Marrow Biopsy or Aspiration
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end of treatment, patients with a confirmed complete response, partial response or stable disease will be followed for up to 2 years to assess time to disease progression. Approximately 80 patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the following European countries: France, Germany, Poland, Sweden and the United Kingdom.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of B-cell CLL by standard clinical and immunophenotypic criteria as specified by the NCI working group revised guidelines for diagnosis and treatment of CLL(32).
- •Binet stages A-C with evidence of active disease requiring treatment by the presence of one or more of the following at the time of study entry:
- •Disease related B symptoms (Fever \> 38C \[100.5F\] for ≥ 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss \> 10% within previous 6 mo.).
- •Evidence of progressive marrow failure as manifested by:
- •A decrease in hemoglobin to \< 10g/dL, or
- •A decrease in platelet count to \< 100 x 10(9)/L within the previous 6 months, or
- •A decrease in absolute neutrophil count (ANC) to \< 1.0 x 10(9)/L within 6 months
- •Progressive lymphocytosis with an increase of \> 50% over a 2 month period, or an anticipated doubling time of \< 6 months.
- •Massive nodes or clusters(i.e., \> 10 cm in longest diameter) or progressive lymphadenopathy.
- •Progressive splenomegaly to \> 2cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinical visits ≥ 2 weeks apart.
Exclusion Criteria
- •Active autoimmune manifestation of CLL such as ongoing hemolytic anemia or ITP
- •History of a second malignancy with the exception of cervical cancer,or resected basal cell carcinoma or other malignancies with no evidence of recurrence 5 or more years since diagnosis.
- •Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).
- •Transformation to an aggressive B-cell malignancy such as Richter's transformation, prolymphocytic leukemia (PLL) or large B-cell lymphoma.
- •Clinical evidence of CNS involvement with CLL.
- •Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives.
- •Treatment with any investigational agent within 4 weeks of study entry.
- •The use of steroids, nonsteroidal anti-inflammatory drugs, regardless of indication (excluding prophylactic use of aspirin for prevention of acute myocardial infarction or stroke)
- •Pregnancy or currently breast feeding.
Arms & Interventions
Chlorambucil
Regime A
Intervention: Chlorambucil
R-etodolac with chlorambucil
Regime B
Intervention: R-etodolac + chlorambucil
Outcomes
Primary Outcomes
Bone Marrow Biopsy or Aspiration
Time Frame: Baseline + 6 months
Overall response rate assessment according to National Cancer Institute-Working Group (NCI-WG) criteria using cytogenetic and biomarker evaluations.
Secondary Outcomes
- Cytogenetic and biomarker evaluations + adverse events(6 months)