- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00285103
SPC2996 in Chronic Lymphocytic Leukaemia
An Open-labelled, International, Multicenter, Dose Escalating, Phase I/II Study of SPC2996,an LNA Antisense Molecule Against Bcl-2, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia
Studieoversigt
Detaljeret beskrivelse
Chronic Lymphocytic Leukaemia (CLL) is the most common leukaemia in adults in the US and most of Western Europe. Many patients suffering from CLL have tumour cells expressing high amounts of Bcl-2 protein. Since over expression of Bcl-2 inhibits apoptosis, it is possible that this gene participates in the pathogenesis of CLL. By lowering the Bcl-2 protein in these tumour cells the cells may go into apoptosis due to changed balance in pro- and anti apoptotic proteins and thereby it might be possible to induce a tumour response.
The study is an open-labelled, international, multicenter, dose escalating phase I/II study where patients receive 6, 3, 2 or 1 dose(s) of SPC2996, a LNA antisense molecule against Bcl-2, over a period of up to 2 weeks, and are followed for 6 months.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Copenhagen, Danmark, 2100
- Rigshospitalet
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Herlev, Danmark, 2730
- KAS Herlev
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Vejle, Danmark, 7100
- Vejle Sygehus
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Leeds, Det Forenede Kongerige, LS1 3EX
- Leeds General Infirmary
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Leicester, Det Forenede Kongerige, LE1 9HN
- MRC Toxicology Unit, University of Leicester
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Manchester, Det Forenede Kongerige, M20 4BX
- Christie Hospital NHS Trust
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Surrey, Det Forenede Kongerige, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Holden Comprehensive Cancer Center, Univ. of Iowa
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Lille, Frankrig, 59037
- Bruno Cazin
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Lyon, Frankrig, 69437
- Mauricette Michellet
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Rouen, Frankrig, 76038
- Centre Henri Becquerel
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Cedex
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Lyon, Cedex, Frankrig, 69495
- Service d'HématologieCentre Hospitalier Lyon-Syd
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- patients with relapsed or refractory Chronic Lymphocytic Leukaemia requiring therapy
- screening blood sample must show circulating lymphocyte count of more then 5 x 109/L and circulating lymphocytes expressing the phenotype CD5+CD20+CD23+.
- The PCR Bcl-2 m-RNA level must be positive
- the patients must be 18 years or older and have given informed consent.
Exclusion Criteria:
- previous treatment with rituximab, alemtuzumab or autologous stem cell transplantation within 6 months prior to Visit 1 or allogeneic stem cell transplantation at any time
- patients that received anti-cancer therapy, glucocorticoids or radiotherapy within 4 weeks prior to Visit 1 and patients with known or suspected transformation of CLL
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Bcl-2 m-RNA levels
Tidsramme: from Day 0 to Day 13
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from Day 0 to Day 13
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Change in Bcl-2 protein expression. Change in Bcl-2 m-RNA levels (and other parameters)
Tidsramme: from Day 0 to Day 14 and during study respectively
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from Day 0 to Day 14 and during study respectively
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Betrand Coiffier, Prof. MD, Centre Hospitalier Lyon Sud, Lyon, France
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SPC2996-101
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