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

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

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

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

22/017

LD-VenEx. LD-VenEx Clinical Study Protocol: Phase 2 study of azacitidine in combination with low dose intensity venetoclax in patients with acute myeloid leukemia with integration of explorative multi-omics and ex vivo drug screening data

2

2023-05-10

Martin Jädersten

22/064

MK3543-006-05 Shorespan-006. A Phase 3 Multi-Center, Randomized, Controlled Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) versus Best Available Therapy (BAT) in Patients with Essential Thrombocythemia who are Resistant to or Intolerant of Hydroxyurea

3

2024-06-01

Anna Ravn Landtblom

23/010

MEDAL. Monitoring for Early Detection of relapse in Acute myeloid Leukemia

Ej tillämpbar

2023-10-12

Martin Jädersten

24/004

MK3543-007 (Shorespan-007). A phase 3, Randomized, Double-blind, Active.Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK3543) versus Hydroxyurea in Cytoreductive Therapy Naive Essential thrombocythemia Partiocipants

3

2024-11-29

Anna Ravn Landtblom

24/065

TAK-079-3002. A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia

3

2024-06-24

Cecilia Karlström

Lymfom

 Nr Namn

Fas

Startdatum Ansvarig prövare

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

Ej tillämpbar

2018-01-01

Anders Österborg

18/032

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

Ej tillämpbar

2019-02-14

Karin Ekström Smedby

18/073

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

2

2019-11-06

Lotta Hansson

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

20/007

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

Ej tillämpbar

2021-09-01

Björn Wahlin

20/058

ALLTogether-1. 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

20/070

PreVent-ACaLL. Short-term combined acalabrutinib and venetoclax treatment of newly diagnosed patients with CLL at high risk of infection and/or early treatment who do not fulfil IWCLL treatment criteria for treatmnet. A randomized study with extensive immune phenotyping

2

2022-08-15

Jeanette Lundin

21/104

BGB3111-LTE1 Roll-overstudie. En öppen, multicenter, långsiktig förlängningsstudie av zanubrutinib (BGB-3111) hos patienter med Bcellsmaligniteter.

4

2022-05-10

Björn Wahlin

22/027

MERLIN. Phase II multicenter clinical trial: Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic countries

2

2023-12-14

Björn Wahlin

22/073

BELLWAVE-011 (MK1026-011). A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Ibrutinib as 1L+ Therapy in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)

3

2024-10-10

Anders Österborg

24/060

HYPERION. Hyper-CVAD/MA for high-risk aggressive B-cell lymphomas: a single-centre academic phase II trial

2

2024-11-08

Björn Wahlin

24/074

Golseek-1. A phase 3, multicenter, Randomized, Double-blind, Placebo-controlled study compairing the efficacy and safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP chemotherapy in participants with Previouslyu untreated High-risk large B-Cell lymphoma.

3

2025-01-24

Kristina Sonnevi

Myelom

 Nr Namn

Fas

Startdatum Ansvarig prövare

22/009

MAGNETISMM-7-studien. A randomised, 2-arm, phase 3 study of elranatamab (PF-06863135) versus lenalidomide in patients with newly diagnosed multiple myeloma who are minimal residual disease-positive after undergoing autologous stem-cell transplantation

3

2022-09-08

Katarina Uttervall

22/043

MajesTEC-7. A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy

3

2022-12-22

Katarina Uttervall

22/044

ODX-MM-001. A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma

1-2

2023-03-28

Katarina Uttervall

Koagulation

 Nr Namn

Fas

Startdatum Ansvarig prövare

19/011

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

Ej tillämpbar

2019-12-05

Roza Chaireti

Övriga studier, flera diagnoser

 Nr Namn

Fas

Startdatum Ansvarig prövare

19/010

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

Ej tillämpbar

2021-12-06

Roza Chaireti

Nr: Forskningsrådets nummer.
Namn: Studiens kortnamn följt av protokollets hela titel.
Fas: Kan vara Fas 1, 2, 3 eller Pilot, kombinationer av dessa, eller Ej tillämpligt.
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 03.07.2025