Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Wir möchten Patientinnen und Patienten mit rezidiviertem Non-Hodgkin-Lymphom (NHL) zur Teilnahme an dieser klinischen Studie mit dem Studienmedikament Betalutin® einladen. Betalutin® besteht aus dem Antikörper Lilotomab, der mit der radioaktiven Substanz Lutetium-177 verbunden ist. Die Studie untersucht die Radioimmuntherapie bei NHL. Wir führen diese Studie durch, um die Sicherheit und Wirksamkeit von Betalutin® zu beurteilen und um herauszufinden, wie es sich im Körper bewegt. Betalutin® ist noch nicht in der Schweiz zugelassen. In dieser Studie wird Betalutin® zusammen mit anderen Medikamenten eingesetzt, die als Vorbehandlung vor der Betalutin®-Injektion gegeben werden, um die Behandlung mit Betalutin® zu verbessern. Alle Patientinnen und Patienten erhalten i) 14 Tage vor Verabreichung von Betalutin® intravenös Rituximab in einer Dosis von 375 mg/m2, ii) intravenös Lilotomab, denselben Antikörper, der auch in Betalutin® enthalten ist, jedoch ohne Radioaktivität. Lilotomab wird innerhalb von 4 Stunden vor Gabe von Betalutin® verabreicht. iii) Betalutin® wird über einen Zeitraum von einigen Minuten in eine Vene injiziert. In dem Teil der Studie, zu dem die Patientin/der Patient eingeladen wird, werden an zwei Patientengruppen unterschiedliche Dosierungen von Lilotomab und Betalutin® getestet. Nach dem Münzwurf-Prinzip werden die Patientinnen/Patienten zufällig einer der beiden Behandlungsgruppen zugeteilt (50:50-Chance). Die Dosis hängt vom Studienarm ab, dem die Patientin/der Patient zugeteilt wird. Der Studienarzt teilt der Patientin/dem Patienten mit, welche Dosis sie/er erhält. Die Teilnahme an dieser Studie dauert 14 Wochen. An den Behandlungszeitraum schliesst eine Nachbeobachtung von 5 Jahren bzw. bis zu einer weiteren Krebstherapie an. In diese Studie aufgenommene Patientinnen und Patienten werden zunächst medizinischen Untersuchungen unterzogen. Dazu zählt: Entnahme einer Gewebeprobe des Tumors und des Knochenmarks; Anfertigung von CT/PET-Aufnahmen.
Malattie studiate(Fonte di dati: BASEC)
Lymphdrüsenkrebs
Health conditions
(Fonte di dati: WHO)
Non-Hodgkin Lymphoma;Follicular Lymphoma
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Strahlentherapie bei Non-Hodgkin-Lymphom
Interventions
(Fonte di dati: WHO)
Drug: Betalutin
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Rezidiviertes Non-Hodgkin-Lymphom; Männlich oder weiblich im Alter von ≥ 18 Jahren; Vorbehandlung mit mindestens 2 chemo- oder immuntherapeutischen Therapien; Vorbehandlung muss Rituximab/anti-CD20-Wirkstoff und eine alkylierende Substanz beinhalten; Erlaubt ist auch eine vorherige Idelalisib-Exposition oder Exposition mit anderen Inhibitoren der Phosphatidylinositol-3-Kinase (PI3K); Die Patientinnen/Patienten müssen refraktär gegenüber der letzten Rituximab-/anti-CD20-basierten Behandlung sein, d. h. sie haben nicht auf die Therapie angesprochen.
Criteri di esclusione
(Fonte di dati: BASEC)
Vorherige Stammzelltherapie; Vorherige Stammzelltransplantation; Transformation eines follikulären Lymphoms in ein diffus grosszelliges B-Zell-Lymphom zum Zeitpunkt des Screenings; Vorherige Ganzkörperbestrahlung; Vorherige Anti-Lymphom-Therapie (Chemotherapie, Immuntherapie oder Behandlung mit anderer Prüfmedikation) innerhalb von 4 Wochen vor Beginn der Studienbehandlung
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Part A and Part C:
Inclusion Criteria:
- Histologically confirmed (by WHO classification) relapsed incurable non- Hodgkin
B-cell lymphoma of following subtypes; follicular grade I-IIIA, marginal zone, small
lymphocytic, lymphoplasmacytic, mantle cell.
- Age = 18 years
- A pre-study WHO performance status of 0-1
- Life expectancy should be = 3 months
- <25% tumour cells in bone marrow biopsy
- Measurable disease by radiological methods
Exclusion Criteria:
- Absolute Neutrophil Counts (ANC) = 1.5 x 109 /l
- Platelet count = 150 x 109 /l
- Total bilirubin = 30 mmol/l
- ALP and ALAT = 4x normal level
- Creatinine = 115 µmol/l (men), 97 µmol/l (women))
- Known CNS involvement of lymphoma
- Previous total body irradiation
- Known history of HAMA
- Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study
treatment. Pretreatment with rituximab is allowed
- Previous hematopoietic stem cell transplantation (autologous and allogenic)
- Previous treatment with radioimmunotherapy
- Receipt of live, attenuated vaccine within 30 days prior to enrolment
- Test positive for hepatitis B (HBsAg and anti-HBc)
- A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any
excipient used in rituximab, HH1 or Betalutin
Part B:
Inclusion Criteria:
Histologically confirmed (by WHO classification) relapsed non-Hodgkin B-cell FL (follicular
grade I-IIIA).
2. Male or female aged = 18 years. 3. Received at least 2 prior anti-neoplastic or
immunotherapy-based regimens (maintenance therapy following a CR/PR is not considered to be
a separate line of therapy).
4. Prior therapy must include rituximab/anti-CD20 agent and an alkylating agent. Prior
exposure to other systemic anti-neoplastic agents (including idelalisib or other
phosphatidylinositol 3-kinase (PI3K) inhibitors etc.) is also allowed.
5. Patients must be refractory to any previous regimen containing rituximab or an anti-CD20
agent, defined as: no response (no CR/PR) during therapy, or a response (CR/PR) lasting
less than 6 months after the completion of a regimen including rituximab/anti-CD20 therapy
(including occurrence of progressive disease (PD) during rituximab/anti-CD20 maintenance
therapy, or within 6 months of completion of maintenance therapy).
6. WHO performance status of 0-2. 7. Life expectancy of = 3 months. 8. Bone marrow tumour
infiltration < 25% (in biopsy taken from a site not previously irradiated).
9. Measurable disease by CT or MRI: longest diameter (LDi) > 1.5 cm for nodal lesion, LDi >
1.0 cm for extra nodal lesion within 28 days prior to start of treatment.
10. ANC = 1.5 x 109/L. 11. Platelet count = 100 x 109/L . 12. Haemoglobin = 9.0 g/dL. 13.
Total bilirubin =1.5 x upper limit of normal (ULN) (except patients with documented
Gilbert's syndrome [< 3.0 mg/dL]).
14. Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or ALP = 2.5 x
ULN (or = 5.0 x ULN with liver involvement by primary disease).
15. Adequate renal function as demonstrated by a serum creatinine < 1.5 x ULN. 16. Women of
childbearing potential must:
1. understand that the study medication is expected to have teratogenic risk.
2. have a negative serum beta human-chorionic gonadotropin (ß-HCG) pregnancy test at
screening.
3. commit to continued abstinence from heterosexual intercourse (excluding periodic
abstinence or the withdrawal method) or begin a highly effective method of birth
control with a Pearl-Index < 1%, without interruption, from 4 weeks before starting
study medication, throughout study medication therapy and for 12 months after end of
study medication therapy, even if she has amenorrhoea. Apart from abstinence, highly
effective methods of birth control are: i. Combined (oestrogen and progestogen
containing) hormonal contraception associated with inhibition of ovulation (oral,
intravaginal, transdermal).
ii. Progestogen-only hormonal contraception associated with inhibition of ovulation ((oral,
injectable, implantable) iii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing
system (IUS). v. Bilateral tubal occlusion. vi. Vasectomised partner. 17. Male patients
must agree to use condoms during intercourse throughout study medication therapy and the
following 12 months.
18. The patient is willing and able to comply with the protocol, and agrees to return to
the hospital for follow-up visits and examination.
19. The patient has been fully informed about the study and has signed the informed consent
form.
20. Negative HAMA test at screening. 21. Negative Hepatitis B (negative HBsAG and
anti-HBC), Hepatitis C and HIV test at screening
Exclusion Criteria:
Prior hematopoietic allogenic stem cell transplantation. Patients with a prior autologous
stem cell transplanted (SCT) are excluded unless at least two years have elapsed since
transplantation and the patient has been without grade =1 Graft vs Host Disease (GvHD) in
the 8 weeks before date of consent.
3. Evidence of histological transformation from FL to diffuse large B-cell lymphoma (DLBCL)
at time of screening. 4. Previous total body irradiation. 5. Prior anti-lymphoma therapy
(chemotherapy, immunotherapy or other investigational agent) within 4 weeks prior to start
of study treatment (corticosteroid treatment at doses of = 20 mg/day, topical or inhaled
corticosteroids, granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage
colony-stimulating factor [GM-CSF] are permitted up to 2 weeks prior to start of study
treatment). Note: excludes pre-treatment with rituximab as part of this study.
6. Patients who are receiving any other investigational medicinal products. 7. Patients
with known or suspected CNS involvement of lymphoma. 8. History of a previous treated
cancer except for the following:
a. adequately treated local basal cell or squamous cell carcinoma of the skin. b. cervical
carcinoma in situ. c. superficial bladder cancer. d. localised prostate cancer undergoing
surveillance or surgery. e. localised breast cancer treated with surgery and radiotherapy
but not including systemic chemotherapy.
f. other adequately treated Stage 1 or 2 cancer currently in CR. 9. Pregnant or
breastfeeding women. 10. Exposure to another CD37 targeting drug. 11. A known
hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient
used in rituximab, lilotomab, or Betalutin.
12. Has received a live-attenuated vaccine within 30 days prior to enrolment. 13.
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
19 feb 2013
Inserimento del primo partecipante
1 dic 2012
Stato di reclutamento
Active, not recruiting
Titolo scientifico
(Fonte di dati: WHO)
A Phase I/II Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.
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: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 1/Phase 2
Punti finali primari
(Fonte di dati: WHO)
Part A, Phase I;Part A, Phase IIa;Part B, Phase II
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)
Chur
Paesi di esecuzione
(Fonte di dati: WHO)
Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Czechia, Denmark, Finland, France, Hungary, Ireland, Israel, Italy, Korea, Netherlands, Norway, Poland, Republic of, Singapore, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Prof. Dr. med. Ulrich Mey
+41 (0)81 256 66 46
ulrich.mey@ksgr.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Arne Kolstad, MD, PhD;Clinical Trials
Oslo University Hospital
clinicaltrials@nordicnanovector.com
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Arne Kolstad, MD, PhD;Clinical Trials
Oslo University Hospital
clinicaltrials@nordicnanovector.com
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)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
14.09.2021
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2018-00410
Secondary ID (Fonte di dati: WHO)
EudraCT: 2011-000033-36
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