Status:
TERMINATED
Safety and Efficacy of SDX-101 (R-Etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Cephalon
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Lymphoc...
Eligibility Criteria
Inclusion
- 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.
- No prior chemotherapy for CLL.
- Age ≥ 18 at signing of informed consent.
- World Health Organization (WHO) performance status ≤ 0-2 (Appendix B).
- Platelet count \> 50,000/μL, hemoglobin \> 8.0 g/dl and absolute neutrophil count \> 1000/μL.
- Renal function ≤ 1.5 x upper limit normal (blood urea nitrogen \[BUN\], serum creatinine)
- Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
- Female patients of childbearing potential must have a negative pregnancy test (serum or urine Beta-human chorionic gonadotropin, Beta-HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 2 months following completion of treatment.
- Signed EC/IRB-approved informed consent by patient prior to all study related procedures.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00151736
Start Date
September 1 2004
End Date
February 1 2008
Last Update
June 11 2012
Active Locations (22)
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1
Chef du Service d'Hematologie Clinique CHU Clemenceau
Caen, France
2
Service maladies du sang CHRU- rue Michel Polonovski
Lille, France
3
Charité - Benjamin Franklin Medizinische Klinik III Hämatologie, Onkologie und Transfusionsmedizin
Berlin, Germany
4
Internistische Schwerpunktpraxis
Erlangen, Germany