Status:
COMPLETED
A Phase I/II Study to Assess the Safety and Tolerability of APO866 for the Treatment of Refractory B-CLL
Lead Sponsor:
Valerio Therapeutics
Conditions:
B-cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II study is designed to determine the safety and tolerability of APO866 for the treatment of refractory B-CLL not amenable to aHSCT. APO866 has shown to induce growth inhibition in cultur...
Detailed Description
B-CLL is one of the most common types of leukemia, remains incurable, and has only limited therapeutic options available including alkylating agents and fludarabine. The identification of new, selecti...
Eligibility Criteria
Inclusion
- Immunophenotypic (monoclonal population of mature CD5+, CD19+, CD23+) confirmed diagnosis of B-CLL
- Diagnosis of progressive symptomatic B-CLL requiring therapy (Revised NCI-sponsored Working Group guidelines for CLL
- Relapsed or refractory disease or intolerant to ≥ 2 prior systemic therapy. (containing either a purine analog or an alkylating agent). Patient is not amenable to aHSCT
- ECOG Performance Status \< 2
- Age \> 18 years, of either sex
- Female patients with childbearing potential must be using a hormonal contraceptive, intra uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Women of childbearing potential must have a negative serum or urinary hCG pregnancy test within 7 days prior to Study Day 1 (SD1)
- Male patients, who are not surgically sterile, must use a condom with spermicide for the duration of the study and 3 months thereafter
- Have given written informed consent, prior to any study related procedure not part of the patient's normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Exclusion
- Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 weeks preceding SD1
- Use of prohibited medication due to CYP3A4 metabolism of APO866, as specified in Section 6.6.2. concomitant use of these drugs will not be allowed during the study
- Uncontrolled medical conditions, requiring surgical or pharmacological treatment (exceptions must be approved by the Medical Responsible of the study)
- Active infection requiring systemic antibiotics
- Serious concomitant disease (e.g. significant cardiac disease)
- History of second cancer that was treated with curative intent and in complete remission for \< 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
- Inadequate bone marrow function: platelets \< 75x10\^9/L without transfusion in the preceding 2 weeks, ANC \< 1,0x10\^9/L without growth factor support, abnormal coagulation APTT and PT
- Platelet-refractory state due to platelet alloimmunization
- Inadequate liver function: total bilirubin \> 1.5x upper limit of normal values (ULN), AST, ALT, or alkaline phosphatase \> 2.5x ULN
- Inadequate renal function: serum creatinine \> 1.5x ULN
- Retinopathy, history of retinal laser surgery, or an ERG \< 50% of normal
- Pregnant or lactating female
- Known allergy to reagents in the study drug (APO866 or propylene glycol).
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00435084
Start Date
February 1 2007
End Date
April 1 2009
Last Update
September 23 2015
Active Locations (4)
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1
Department of Heamtology, Cardiff and Vale NHS Trust
Cardiff, United Kingdom, CF14 4 WX
2
Department of Heamtology, Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
3
Department of Heamtology, Bart's and the London NHS Trust
London, United Kingdom, EC1A 7BE
4
Department of Heamtology, University Hospital of NHS Trust
Nottingham, United Kingdom, NG5 1PB