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NCT01796171 | SNCTP000003419

Radioimmuntherapie mit Lutetium-(177Lu)-Lilotomab-Satetraxetan (Betalutin®) zur Behandlung von Non-Hodgkin-Lymphom

Data source: BASEC (Imported from 09.12.2019), WHO (Imported from 01.12.2019)
Changed: 22.09.2019
Disease category: Non-Hodgkin-Lymphom

Brief description of trial (Source of data: 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.

Health conditions investigated (Source of data: BASEC)

Lymphdrüsenkrebs

Health conditions (Source of data: WHO)

Non-Hodgkin Lymphoma;Follicular Lymphoma

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Strahlentherapie bei Non-Hodgkin-Lymphom

Interventions (Source of data: WHO)

Drug: Betalutin

Criteria for participation in trial (Source of data: 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.

Exclusion criteria (Source of data: 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 (Source of data: WHO)


Part A:

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).

- Male or female aged = 18 years.

- Received at least 2 prior chemotherapy- or immunotherapy-based regimens. Prior therapy
must include a rituximab/anti-CD20 agent and alkylating agent. Prior exposure to other
systemic anti-neoplastic agents (including idelalisib or other PI3K inhibitors) is
also allowed.

- Patients must be refractory to any previous regimen containing rituximab/anti-CD20
agent, defined as no response (no CR or PR) during therapy or a response (CR/PR)
lasting less than 6 months after the completion of a regimen of 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).

- WHO performance status of 0-2.

- Life expectancy of = 3 months.

- Bone marrow tumour infiltration < 25% (in biopsy taken from a site not previously
irradiated).

- Measurable disease by CT or MRI: longest diameter (LDi) > 1.5 cm for nodal lesion, LDi
> cm for extra nodal lesion within 28 days prior to start of treatment.

- ANC = 1.5 x 109/L.

- Platelet count = 150 x 109/L.

- Haemoglobin = 9.0 g/dL.

- Total bilirubin = 1.5 x upper limit of normal (ULN) (except patients with documented
Gilbert's syndrome [< 3.0 mg/dL]).

- 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).

- Adequate renal function as demonstrated by a serum creatinine < 1.5 x ULN.

- Negative HAMA test at screening.

- Negative test at screening for Hepatitis B (negative HBsAG and anti-HBC), Hepatitis C
and HIV.

Exclusion Criteria:

- Prior hematopoietic allogenic stem cell transplantation.

- Prior autologous stem cell transplantation.

- Evidence of histological transformation from FL to DLBCL at time of screening.

- Previous total body irradiation.

- 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, G-CSF or 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.

- Patients with known or suspected CNS involvement of lymphoma.

- History of a previous treated cancer except for the following: adequately treated
local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
superficial bladder cancer, localised prostate cancer undergoing surveillance or
surgery, localised breast cancer treated with surgery and radiotherapy but not
including systemic chemotherapy, other adequately treated Stage 1 or 2 cancer
currently in CR.

- Exposure to another CD37 targeting drug.

- A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any
excipient used in rituximab, lilotomab, or Betalutin.

- Has received a live-attenuated vaccine within 30 days prior to enrolment.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT01796171

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT01796171

Further information on trial

Date trial registered

19.02.2013

Incorporation of the first participant

01.12.2012

Recruitment status

Recruiting

Academic title (Source of data: WHO)

A Phase I/II Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Source of data: WHO)

Phase 1/Phase 2

Primary end point (Source of data: WHO)

Part B, Phase IIb;Part A, Phase IIa;Part A, Phase I

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Chur

Countries (Source of data: 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

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Dr. med. Karin Hohloch
+41 (0)81 256 66 46
karin.hohloch@ksgr.ch

Contact for general information (Source of data: WHO)

Arne Kolstad, MD, PhD;Clinical Trials
Oslo University Hospital
clinicaltrials@nordicnanovector.com

Contact for scientific information (Source of data: WHO)

Arne Kolstad, MD, PhD;Clinical Trials
Oslo University Hospital
clinicaltrials@nordicnanovector.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Nordic Nanovector

Additional sponsors (Source of data : WHO)

ICON Clinical Research

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2018-00410

Secondary ID (Source of data: WHO)

EudraCT: 2011-000033-36