Status:
COMPLETED
A Study of APO866 for the Treatment of Cutaneous T-cell Lymphoma
Lead Sponsor:
Valerio Therapeutics
Conditions:
Cutaneous T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced forms of cutaneous T-cell lymphoma (CTCL). APO866 has shown to induce growth ...
Detailed Description
CTCL is the most frequent occurring cutaneous non-Hodgkin lymphoma characterized by an indolent and protracted course of patches, plaques and tumors. It is highly symptomatic, debilitating, disfigurin...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of CTCL including mycosis fungoides and Sézary syndrome
- Stage Ib to IVb disease (AJCC TNM staging, see Appendix B)
- Relapsed or refractory disease or intolerant to ≥ 2 prior systemic therapy. PUVA, topical nitrogen mustard, spot or total skin electron beam therapy or other radiotherapy, oral retinoids, immunotherapy (e.g. interferon-α, denileukin difitox, alemtuzumab) or mono- or poly-chemotherapy regimen will be considered systemic therapy.
- 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
- Male patients, who are not surgically sterile, must use a condom with spermicide for the duration of the study
- 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any study related procedure not part of the patient's normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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 2 months preceding SD1
- Have had PUVA, topical nitrogen mustard, spot or total skin electron beam therapy, oral retinoids, or any, immunotherapy (e.g. interferon-α, denileukin difitox, alemtuzumab) or chemotherapy regimen within 2 weeks of SD1. Patients must have recovered from all acute toxicities.
- Evidence of CNS lymphoma
- 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 Study Director).
- Serious concomitant disease (e.g. significant cardiac disease) are not eligible
- Primary or acquired thrombocytopenia
- Inadequate bone marrow reserve: WBC \< 3.5x10\^9/L, neutrophils \< 1.0x10\^9/L, thrombocytes \< 100x10\^9/L, Hb \< 8.5 g/dL or coagulation abnormalities
- Inadequate liver function: total bilirubin \> 1.5 x upper limit of normal values (ULN), AST, ALT, or alkaline phosphatase \> 2.5 x ULN
- Have inadequate renal function, defined by serum creatinine \> 250 μmol/L
- Retinopathy, history of retinal laser surgery, or an ERG \< 50% of normal
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00431912
Start Date
February 1 2007
End Date
September 1 2011
Last Update
July 8 2015
Active Locations (5)
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1
Department of Dermatology, Medical University Graz
Graz, Austria, 8036
2
Deapartment of Dermatology
Créteil, France, 94010
3
department of Dermatologie, Hotel Dieu
Nantes, France, 44093
4
University Clinic for Dermatology, Medical Faculty of Mannheim of the Heidelberg University
Mannheim, Germany, 68167