APO866 for B-Cell Leukaemia. An open phase I/II clinical study assessing the safety and tolerability of APO866 in patients with refractory B-cell lymphocytic leukaemia not amenable to allogeneic hemopoietic stem cell transplantatio

Phase 1

• Conditions: 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

• Registration Number: EUCTR2006-002850-31-GB
• Lead Sponsor: TopoTarget A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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any study related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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

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 < 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
•Inadequate bone marrow function: platelets = 75x109/L without transfusion in the preceding 2 weeks, ANC = 1,0x109/L without growth factor support, abnormal coagulation APTT an 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified