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SNCTP000001327 | NCT02451111

SAKK 35/14 Rituximab in Kombination mit Ibrutinib oder Placebo in nicht vorbehandelten Patienten mit einem fortgeschrittenen follikulären Lymphom mit Therapiebedarf. Eine randomisierte, doppelblindePhaseIIStudie

Base di dati: BASEC (Importata da 24.11.2020), WHO (Importata da 22.11.2020)
Cambiato: 01.11.2020
Categoria di malattie: Linfoma non Hodgkin

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Mit der Studie SAKK 35/14 will man nun herausfinden, ob die Kombination der Wirkstoffe Rituximab und Ibrutinib für die Patienten noch mehr Vorteile hat. Diese Kombination hat sich in anderen Studien bereits als gut verträglich und wirksam erwiesen. In der Studie SAKK 35/14 erhalten Patienten mit follikulärem Lymphom, die erstmals eine Behandlung mit Medikamenten benötigen, während zwei Jahren entweder Rituximab und placebo oder eine Kombinationsbehandlung aus Rituximab und Ibrutinib. Während der Therapie und auch danach werden die Patienten regelmässig vom Arzt kontrolliert, um die Verträglichkeit und Wirksamkeit der Behandlung zu überwachen . Es handelt sich um eine doppel blinde Studie (dh. weder der Patient noch der Arzt wissen, ob sie Ibrutinib oder Placebo erhalten).

Malattie studiate (Fonte di dati: BASEC)

Fortgeschrittenen follikulären Lymphom

Health conditions (Fonte di dati: WHO)

Follicular Lymphoma

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

Rituximab in Kombination mit Ibrutinib oder Placebo während 24 Monaten

Interventions (Fonte di dati: WHO)

Drug: Ibrutinib;Drug: Rituximab

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

Histologisch bestätigtes fortgeschrittenen follikulären (FL) Lymphom mit Therapiebedarf; mind. eine messbare Läsion ≥ 15 mm; ausreichende Blut, Leber, NIerenwerte

Criteri di esclusione (Fonte di dati: BASEC)

Vorherige Therapie gegen das FL; Behandlung mit CYP3A-Inhibitoren und Antikoagulantien

Inclusion/Exclusion Criteria (Fonte di dati: WHO)


Inclusion Criteria:

- Written informed consent according to ICH/GCP guidelines

- Histologically confirmed FL CD20+; grade 1, 2, 3a; stage III+IV; stage II not suitable
for radiotherapy; all FLIPI

- Tumor specimens (slides or block) available for pathological review

- In need of systemic therapy (at least one of the following indications must be
fulfilled):

- Symptomatic disease

- Bulky disease (= 6 cm)

- Steady, clinically significant progression over at least 3 months of any tumor
lesion

- B-symptoms (weight loss > 10% in 6 months, drenching night sweats, fever > 38°C
not due to infection)

- Anemia (hemoglobin < 100 g/L) or thrombocytopenia (platelets 50-100 x 109/L) due
to lymphoma

- At least one two-dimensionally measurable lesion with a longest diameter (LDi) = 15 mm
in contrast-enhanced 18F-FDG PET/CT* scan

- FDG-avid tumor lesion in contrast-enhanced 18F-FDG PET/CT* scan

- Age 18-85 years

- WHO performance status 0-2

- Adequate bone marrow function:

- Absolute neutrophil count (ANC) > 1.0 x 109/L independent of growth factor
support

- Platelets = 100 x 109/L or = 50 x 109/L if bone marrow involvement independent of
transfusion support in either situation

- Adequate hepatic function:

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x upper
limit of normal (ULN)

- Total bilirubin = 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or
of non-hepatic origin

- Adequate renal function:

• Serum creatinine = 2 x ULN and corrected calculated creatinine clearance = 40
mL/min/1.73m2.

- Women of childbearing potential have a negative serum (beta-human chorionic
gonadotropin) or urine pregnancy test at Screening.

- Patient compliance and geographic proximity allow proper staging and follow-up.

Exclusion Criteria:

- Tumor bulk requiring fast response

- Known central nervous system lymphoma

- Previous systemic FL therapies

- Major surgery 4 weeks prior to randomization

- Previous or concomitant malignancy diagnosed within 3 years with the exception of
adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer

- History of stroke or intracranial hemorrhage within 6 months prior to randomization

- Clinically significant cardiovascular diseases such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by
the New York Heart Association Functional Classification

- Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or
active Hepatitis B Virus infection or any uncontrolled active systemic infection
requiring intravenous (i.v.) antibiotics

- Concomitant diseases that require anticoagulation with warfarin or equivalent vitamin
K antagonists (eg. phenprocoumon), factor Xa inhibitors (e.g. rivaroxaban, apixaban),
direct thrombin inhibitors (e.g. dabigatran) or platelet inhibitors/antiplatelet
agents. Aspirin is allowed (up to 300 mg/d).

- Concomitant diseases that require treatment with strong or moderate CYP3A inhibitors
(see http://medicine.iupui.edu/clinpharm/ddis/clinical-table/)

- Any concomitant drugs contraindicated for use with the trial drugs according to the
approved product information or known hypersensitivity to trial drugs

- Concurrent treatment with other experimental drugs or other anticancer therapy,
treatment in a clinical trial within 30 days prior to trial entry

- Vaccinated with live, attenuated vaccines 4 weeks prior to randomization

- Any life-threatening illness, medical condition, or organ system dysfunction which, in
the Investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue
risk

- Psychiatric disorder precluding understanding information of trial related topics,
giving informed consent or interfering with compliance for oral drug intake

- Women who are pregnant or breastfeeding

- Patients regularly taking corticosteroids during the last 4 weeks, unless administered
at a dose equivalent to Prednisone = 15 mg/day for indications other than lymphoma or
lymphoma-related symptoms

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT02451111

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02451111

Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

19.05.2015

Inserimento del primo partecipante

06.11.2015

Stato di reclutamento

Active, not recruiting

Titolo scientifico (Fonte di dati: WHO)

Rituximab With or Without Ibrutinib for Untreated Patients With Advanced Follicular Lymphoma in Need of Therapy. A Randomized, Double-blinded, SAKK and NLG Collaborative Phase II Trial.

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Fase (Fonte di dati: WHO)

Phase 2

Punti finali primari (Fonte di dati: WHO)

CR at 24 months determined by PET/CT scan by the IRR panel

Punti finali secondari (Fonte di dati: WHO)

CR at 30 months determined by PET/CT scan by the IRR panel;MRD evaluation;Overall response (OR);Duration of complete response (DUR);Progression-free survival (PFS) (PFS);Event-free survival (EFS);Time to next anti-lymphoma therapy (TTNT);Adverse Events (AEs)

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Aarau, Baden, Basilea, Bellinzona, Berna, Brig, Bruderholz, Chur, Ginevra, Liestal, Luzern, Olten, San Gallo, Sion, Thun, Winterthur, Zurigo

Paesi di esecuzione (Fonte di dati: WHO)

Austria, Denmark, Finland, Norway, Sweden, Switzerland

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

Secondini Chiara
+41 31 389 91 91
trials@sakk.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Emanuele Zucca, Prof;Bjørn Østenstad, MD;Björn Wahlin, MD
Oncology Institute of Southern Switzerland IOSI, Bellinzona;Oslo University Hospital;Karolinska University Hospital, Stockholm

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Emanuele Zucca, Prof;Bjørn Østenstad, MD;Björn Wahlin, MD
Oncology Institute of Southern Switzerland IOSI, Bellinzona;Oslo University Hospital;Karolinska University Hospital, Stockholm

Responsabile della sperimentazione

Sponsor principale (Fonte di dati: WHO)

Swiss Group for Clinical Cancer Research

Altri sponsor (Fonte di dati: WHO)

Nordic Lymphoma Group

Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)

Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)

Comitato etico cantonale Ticino

Altri numeri di identificazione delle sperimentazioni

Secondary ID (Fonte di dati: WHO)

2015-001487-19
SNCTP000001327
SAKK 35/14