Kliniska studier vid Tema Cancer

– Studier öppna för inklusion inom ME Cellterapi och Allogen stamcellstransplantation –

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.

Cellterapi och Allogen stamcellstransplantation

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

18/060

Predicting fatigue after allo HSCT. Predicting chronic fatigue and cognitive dysfunction after allogeneic hematopoietic stem cell transplant.

Ej tillä

2019-01-31

Katarina Le Blanc

Eritrea Gebemskl

100

81

19/020

CCTL019G2201J- CASSIOPEJA. A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

2

2022-02-10

Jacek Toporski

Eleni Fyseki

23

0

19/029

LTFU - CAR T-Cell. Long Term Follow-Up of Patients Exposed to Lentiviral- Based CD19 directed CAR T-Cell Therapy)

3

2020-04-15

Stephan Mielke

Kirsti Niemelä

5

2

19/053

AdaptNK- Del 1. Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (Adapt-NK) for High-Risk Myeloid Diseases as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation” and “Collection of donor cells for development of NK cell therapy

1-2

2019-02-01

Andreas Björklund

Josephine Johansson för del 1

10

0

20/015

Transcend FL. A phase 2,open-label, single-arm, multicohort, multicenter trial to evaluate the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL)

2

2021-02-01

Stephan Mielke

Kirsti

4

6

20/054

Allovir AVM-003-HC. Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR-105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

3

2021-12-01

Anna Nordlander

Eleni Fyseki

12

1

20/062

Alexion 1210 TMA-313. A Phase 3, Open-label, Randomized, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT

3

2022-09-14

Ksenia Boriskina

Eleni Fyseki

2

2

20/089

PerCent-aCent. Personcentrerad vård inom allo-HSCT

Ej tillä

2021-02-12

Jeanette Winterling

Jeanette Winterling

20

11

21/011

Zuma-4. A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

1-2

2022-02-18

Jacek Toporski

Eleni Fyseki

14

0

21/086

NMDSG14-B-2. A phase II multicenter single-armed study using subject-specific minimal residual disease markers to adopt treatment after allogeneic stem cell transplantation for subjects with myelodysplastic syndrome - MDS

2

2022-12-16

Andreas Björklund

Alex Perstar

30

3

21/087

Cloudin-6 BNT211-01. Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors

1-2

2023-05-28

Stephan Mielke

Kirsti / Mette för Solna prescreening

0

0

21/091

AlloVir-ADENO (ALVR105) . Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

3

2022-05-31

Anna Nordlander

Eleni Fyseki

4

1

22/047

IDUNN Trial. A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

3

2023-04-05

Stephan Mielke

Moa Hofmann

5

0

22/055

ALLOVIR P105-401 (LTFU). Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel (ALVR105)

Ej tillä

2023-05-11

Anna Nordlander

Eleni Fyseki

0

0

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 29.03.2024