The medical condition for this clinical trial is B. cell chronic lymphocytic leukemia. MedDRA version: 8.1 Level: LLT Classification code 10003894 Term: B-cell chronic lymphocytic leukaemia/prolymphocytic leukaemia/small lymphocytic lymphoma refractory
Conditions
Interventions
Product Name: N-[4-(benzoylpiperidin-4-yl)butyl]-3-(pyridin-3-yl)acrylamide
Product Code: APO866
Pharmaceutical Form: Solution for injection
INN or Prop
Sponsors
TopoTarget A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are: •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 (Cheson 1996: see Appendix B) •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 (see Appendix C) •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any study related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The exclusion criteria are: •Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 weeks preceding SDI. •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. •Use of biphosphonate drugs during the 30 days preceding the APO866 perfusion and during the treatment period. •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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not Applicable ; Main Objective: The main objectives of this study are: 1. To asses the safety and the tolerability of 1 cycle of APO866, administered by continuous intravenous infusion, in patients with refractory B-cell chronic lymphocytic leukemia (B-CLL) non amenable to allogeneic hematopoietic stem cell transplantation (hASCT). 2. To evaluate the effect of APO866 on leukemic B-cells in this population of patients. ; Primary end point(s): The primary endpoints are: •To assess safety including adverse and serious events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with refractory B-LL not amenable to aHSCT. •To measure the effects of APO866 on the number of leukemic B-cells compared to the number of B-cells at baseline •To measure the effects of APO866 on the number of leukemic CD38+ cells compared to the number of CD38+ at baseline, as measured by FACS analysis •Correlative analysis will be performed to assess: -Sensitivity of B-CLL in vivo and ex vivo -CD38 expression of the leukemic cells with clinical outcome -Immunophenotype, if available, will be correlated with clinical outcome. | — |
Countries
United Kingdom
Outcome results
None listed