Kliniska studier vid Tema Cancer

–Studier öppna för inklusion inom PO Hematologi–

Här visas de studier som är öppna för patientinklusion inom den medicinska enheten (ME). Studierna är uppdelade på de olika patientflödena. Vidare visas ansvarig prövare, forskningssjuksköterska och planerad och aktuell inklusion inom temat (visas ej utanför Karolinska). Listan uppdateras minst en gång i veckan. -Längst ner finns en förklaring till de olika kolumnerna.

Benmärgssvikt och leukemi

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

18/086

HEAT-AML. Hydroxyurea-Enhanced Ara-C Treatment of Adult Acute Myeloid Leukaemia) A randomised phase II multi-centercentre study to assess the tolerability and efficacy of the addition of hydroxyurea to standard ara-C and daunorubicin-based therapy for adults (age ≥ 18 years of age) with newly diagnosed acute myeloid leukaemia (AML)

2

2020-09-07

Martin Jädersten

Janelle Cederlund

24

14

19/010

Labmarkörer MPN-patienter . Labmarkörer som en del av riskbedömning för trombohemorrhagiska komplikationer hos patienter med myeloproliferativa sjukdomar

Ej tillä

2021-12-06

Roza Chaireti

Eritrea

250

0

19/026

ACE-536-LFTU-001. A PHASE 3B, OPEN-LABEL, SINGLE-ARM, ROLLOVER STUDY TO EVALUATE LONG-TERM SAFETY IN SUBJECTS WHO HAVE PARTICIPATED IN OTHER LUSPATERCEPT (ACE-536) .

3

2020-01-13

Maria Cormery

Ina Helin

4

1

19/051

MAATEO. A phase 1 study in MDS, AML and ALL patients to evaluate safety, tolerability and efficacy of Karonudib

1

2019-10-03

Stefan Deneberg

Kinga Ordyniec

15

9

19/067

ADORE. CINC424H12201 A randomized, open-label, phase I/II open platform study evaluating safety and efficacy of novel ruxolitinib combinations in myelofibrosis patients

1-2

2020-09-03

PA Broliden

Ina Helin

3

1

20/016

HOVON 150. A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy

3

2021-01-27

Martin Jädersten

Alex Perstar

5

1

20/017

HOVON 156. A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by oneyear maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy

3

2021-12-03

Per Anders Broliden

Alex Perstar

5

4

20/018

EVI-3: Combining Active and Passive DNA Hypomethylation. EVI-3: Combining Active and Passive DNA Hypomethylation A multicenter, randomized, parallel-group, placebo-controlled phase II study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine in higher-risk MDS, CMML, and low-blast-count AML

3

2021-04-15

Eva Hellström Lindberg

Josephine Johansson

20

2

Lymfom

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

17/118

BGB-3111-304. An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

3

2018-05-02

Anders Österborg

Sonja Sönnert-Husa

10

13

17/349

Ibru-On-off-studien. A pilot study on intermittent and repeated dosing of ibrutinib in the treatment of patients with advanced-phase chronic lymphocytic leukemia (CLL)

Pilot

2018-01-30

Jeanette Lundin

Sonja Sönnert-Husa

20

21

17/413

Immunologiska lab-studier på patienter med KLL och andra hematol. In vitro studier av immunologiska funktioner hos patienter med kroniska lymfoproliferativa tumörsjukdomar (Myelom, lymfom, KLL) och MGOS: Extra blodprovstagning

2018-01-01

Anders Österborg

Anders Österborg

0

0

18/032

BioLymph. Prospektiv studie av biologi, etiologi och överlevnad vid lymfom (BioLymph)

Ej tillä

2019-02-14

Karin Ekström Smedby

Lylie Mbuyi

200

221

18/073

PRO-Hodgkin. Clinical investigation of PBS proton treatment in Hodgkin lymphoma patients

2

2019-11-06

Lotta Hansson

Annika Giertz

10

6

19/085

POLAR BEAR-studien. R-MINI-CHOP versus R-MINI-CHP in combination with polatuzumab-vedotin, as primary treatment for patients with diffuse large B-cell lymphoma, ≥80 years, or frail ≥75 years – an open label randomized Nordic Lymphoma Group phase III trial - NLG-LBC7 (POLAR BEAR)

2

2021-02-01

Sara Harrysson

Harriet Ryblom

5

2

20/007

DSA-LL-studien. Better and individualised therapy for patients with relapsing lymphoma and leukaemia

Ej tillä

2021-09-01

Björn Wahlin

Lylie Mbuyi

100

5

20/013

LOXO-BTK-18001. A Phase 1/2 Study of Oral LOXO-305 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

1-2

2021-06-10

Anders Österborg

Sonja Sönnert Husa

5

0

20/024

MyPal. Randomiserad klinisk studie av MyPal-applikationen - ett elektroniskt vårdsystem för omhändertagande med patientrapporterade utfall bland vuxna patienter med hematologiska maligniteter (KLL och MDS

3

2021-05-10

Karin Ekström Smedby

Harriet Ryblom

20

14

20/044

GCT3013-01. A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

1-2

2022-02-08

Kristina Sonnevi

Elisabeth Rilegård

0

1

20/045

GCT 3013-02. A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma

1-2

2021-01-18

Björn Wahlin

Annika Giertz

5

9

20/046

GCT3013-05. Trial, a Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma.

3

2021-11-10

Kristina Sonnevi

Harriet Ryblom

0

1

20/058

ALLTogether. ALLTogether1– A Treatment study protocol of the ALLTogether Consortium for children and young adults (1-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)

3

2020-09-01

Joel Joelsson

Elisabeth Rilegård

20

5

20/069

CLL17. A phase 3 multicenter, randomized, prospective, open-label trial of Ibrutinib monotherapy versus fixed-duration venetoclax plus Obinutuzumab versus fixed-duration Ibrutininb plus venetoclax in patients with previously untreated chronic lymphocytic leukemia (CLL)

3

2021-02-28

Jeanette Lundin

Sonja Sönnert Husa

0

0

Myelom

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

17/346

BCMA-MMY1001. A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64007957, a Humanized BCMA x CD3 DuoBody Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

1

2018-08-29

Katarina Uttervall

Karin Bengtsson

20

24

19/034

BiTeMy, CC93269-MM-001. A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY OF CC-93269, A BCMA X CD3 T CELL ENGAGING ANTIBODY, IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA

1

2020-12-15

Johan Lund

Ina

5

5

19/035

DREAMM 5. A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study GSK2857916 as monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)

1-2

2019-11-05

Katarina Uttervall

Karin Bengtsson

5

3

19/074

Cellprotect-ISA-HC-NK. An open, randomised, controlled phase II trial ofCellProtect in combination with isatuximab antibody versus Isatuximab antibody alone as maintenance treatment in patients with Multiple Myeloma undergoing high dose treatment

2

2021-06-02

Johan Lund

Gustav Kutas

60

8

20/071

HexaBody-01 (Gen3014). An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody-CD38) in Relapsed och Refractory Multiple Myeloma and Other Hematologic Malignancies

1-2

2021-05-11

Maria Creignou

Ina Helin

5

3

Koagulation

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

17/337

AHEAD. ADVATE Hemophilia A Outcome Database

4

2011-11-03

Margareta Holmström

Doris Näslin

5

4

17/345

GMHI. Overall hemostatisk potential (OHP)- Metod som kan användas för behandlingskontroll hos patienter med blödningssjukdomar och för mätning av en fibrinolyshämmare (TAFI)

Ej tillä

2015-06-12

Roza Chaireti

Doris Näslin

8

8

19/011

A-EKG-HemA. Kardiovaskulära risker och mikropartiklarnas roll i en åldrade population av patienter med hemofili A under olika behandlingsregim

Ej tillä

2019-12-05

Roza Chaireti

Doris Näslin

40

5

20/080

MO42590 (HemiNorth). Interventional open label multicenter phase 4 study to evaluate quality of life, physical activity and joint health of emicizumab in patients with severe hemophilia a without inhibitors within the nordic countries and a multicenter, non-interventional study evaluating quality of life, physical activity and bleeds in patients with severe hemophilia a without inhibitors on fviii prophylaxis within the nordic countries.

4

2021-06-01

Maria Bruzelius

Doris Näslin

0

2

Övriga studier, flera diagnoser

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

18/029

Commands, ACE-536-MDS-002. A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin alfa for the Treatment of Anemia due to IPSS-R Very Low, Low or Intermediate Risk Myelodyplastic Syndroms (MDS) in ESA Naive Subjects who require Red Blood Cell Transfusions.

3

2019-05-08

Maria Creignou

Ina Helin

4

2

18/072

BosuPeg-studien. A study of efficacy and safety of long-acting low dose ropeginterferon in patients with chronic myeloid leukemia treated with bosutinib from diagnosis: A randomised prospective trial

2

2019-08-31

Leif Stenke

Harriet Ryblom

20

6

Nr: Forskningsrådets nummer.
Namn: Studiens kortnamn följt av protokollets hela titel.
Fas: Kan vara fas 1, 2, 3 eller pilot eller kombinationer av dessa.
Startdatum: Vanligen datum för startmöte eller liknande.
Ansvarig prövare: Den läkare som är ansvarig för studien inom Tema Cancer.
Ansvarig forskn.sköt: Den forskningssjuksköterska som är ansvarig.

CKC, Tema Cancer, Karolinska universitetssjukhuset 21.05.2022