Kliniske studiar

Seksjon for blodsjukdomar har ei eiga gruppe av medarbeidarar som gjer tilbod om, og utførar forskningsbehandling til klinikken sine pasientar. Vi sammarbeider med legane om den praktiske gjennomføringa av dei kliniske studiane.

Har du spørsmål til protokollane er du alltid velkommen til å kontakte oss, vi kan treffes alle kvardagar mellom kl. 8.00-15.00.

Studiar akutt myelogen leukemi

AML
Linje	Alder	Protokoll (Om studien)	Kriterier	Pasientgruppe	Ansvarlig	Open / stengd
1.	> 18	AbbVie M15-656	I/E	A randomized, double-blind, placebo controlled study in patients with AML who has not been treated before. A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy.	BTG / ABB	Open
1.	> 18	AbbVie M16-043	I/E	A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive.	BTG / ABB	Opnar jan/febr 2018
1.	18-65 år	HOVON 132_AML	I/E	Akutt myelogen leukemi eller høy risk Myelodysplastisk syndrom.	BTG / KE	Stengd
≥ 2	> 18	WO29519- MIRROS	I/E	This study is designed to compare overall survival(OS) in participants with relapsed or refractory Acute Myeloid Leukemia (AML) treated with Idasanutlin in combination with Cyterabin versus participants treated with placebo and Cyterabin	BTG / ABB	Open

Kontaktinformasjon

Anita Bøtter-Brevik (ABB)
Studiesjukepleiar
anita.botter-brevik@helse-bergen.no

Kristin Eikevåg (EK)
Studiesjukepleiar
kristin.eikevag@helse-bergen.no

Studier myelomatose

myelomatose
Linje	Alder	Protokoll (Om studien)	Kriterier	Pasientgruppe	Ansvalig	Open / stengd
≥ 3	>18	MK 3475-183	I/E	The purpose of this study is to compare the efficacy of Pomalidomide and low dose dexamethasone with Pembrolizumab (MK-3475) to that of Pomalidomide and low dose dexamethasone without Pembrolizumab in terms of Progression-Free Survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.	BTG/KE	Stengd
1.	> 18	MK3475-185	I/E	The purpose of this study is to compare the efficacy of Lenalidomid and low dose dexamethasone with Pembrolizumab (MK-3475) to that of Lenalidomid and low dose dexamethasone without Pembrolizumab in terms of progression-free survival (PFS) in participants with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant (Auto-SCT).	BTG/KE	Stengd
≥ 3	>18	Artimids	I/E	This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (Pomalidomide) as part of standard care.	PTB/KE	Open
2.	>18	NMSG Carfilzomib studien	I/E	This study evaluates induction therapy with carfilzomib-cyclophosphamide-dexamethasone before salvage high-dose melphalan with autologous stem cell support (HDT) in multiple myeloma patients with relapse after HDT done at diagnosis. In addition, the study evaluates the effect of maintenance therapy after salvage HDT in multiple myeloma. After salvage HDT half of the patients receive maintenance therapy with carfilzomib/dexamethasone while the other half are observed without maintenance therapy.	GT/ABB	Open

Kontaktinformasjon

Anita Bøtter-Brevik (ABB)
Studiesjukepleiar
anita.botter-brevik@helse-bergen.no

Kristin Eikevåg (EK)
Studiesjukepleiar
kristin.eikevag@helse-bergen.no

Studier immunologisk trombocytopeni (ITP)

ITP
Linje	Alder	Protokoll (Om studien)	Kriterier	Pasientgruppe	Ansvarlig	Open / stengd
≥ 2	≥18	The Prolonging Trial	I/E	This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance therapy may prolong the effect of Rituximab in immune thrombocytopenia.	THT/ABB	Open

Kontaktinformasjon

Anita Bøtter-Brevik (ABB)
Studiesjukepleiar
anita.botter-brevik@helse-bergen.no

Studier kronisk lymfatisk leukemi (KLL)

KLL
Linje	Alder	Protokoll (Om studien)	Kriterier	Pasientgruppe	Ansvarlig	Open / stengd
≥ 2	> 18	AbbVie M15- 550	I/E	Open-Label, Single Arm, Phase 3b, Multi-Center. Study Evaluating the Efficacy of Venetoclax(ABT-199) in Relapsed/Refractory Subjects withChronic Lymphocytic Leukemia (CLL) (VENICE I)	ABAH/ ABB	Open

Kontaktinfomasjon

Anita Bøtter-Brevik (ABB)
Studiesjukepleiar
anita.botter-brevik@helse-bergen.no

Studier kronisk myelogen leukemi (KML)

KML
Linje	Alder	Protokoll (Om studien)	Kriterier	Pasientgruppe	Ansvarlig	Open / stengd
≥ 2		DASTOP2 TRIAL	I/E	Persistence of major molecular remission in chronic myeloid leukemia after a second stop of TKI Treatment in patient who failed an initial stop attempt	BTG / KE	Open
≥ 2	≥18	Optic (Ariad)	I/E	The purpose of this study is to compare and characterize the efficacy and safety of ponatinib in patients with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in a range of doses.	BTG / KE	Stengd

Kontaktinformasjon

Kristin Eikevåg (EK)
Studiesjukepleiar
kristin.eikevag@helse-bergen.no

Studier myelodysplastisk syndrom (MDS)

MDS
Linje	Alder	Protokoll (Om studien)	Kriterier	Pasientgruppe	Ansvarlig	Open / stengd
1.	>18	CC-5013-MDS-010	I/E	A prospective non-interventional post-authorization safety study (PASS), designed as a disease registry of patient with transfusion dependent IPSS low or intermediate-1-risk myelodysplastic syndrome (MDS) and isolated del (5q). Medical product: Revlimid. Active substance: Lenalidomid	AOK / KE	Open
1.	>18	NMDSG14B	I/E	This study aims to develop highly sensitive methods for early detection of relapse based on the patient’s unique mutations. Initially, a mutational screen is being performed. Primers directed against these mutations will be constructed and presence of mutations will be followed in bone marrow and blood frequently after transplantation.	AOK / ABB	Open

Kontaktinformasjon

Anita Bøtter-Brevik (ABB)
Studiesjukepleiar
anita.botter-brevik@helse-bergen.no

Kristin Eikevåg (EK)
Studiesjukepleiar
kristin.eikevag@helse-bergen.no