Clinical trial • Phase II • Oncology

Etoposide phosphate for Primary central nervous system lymphoma | Relapsed or refractory primary central nervous system lymphoma

Phase II trial of Etoposide phosphate for Primary central nervous system lymphoma | Relapsed or refractory primary central nervous system lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Primary central nervous system lymphoma | Relapsed or refractory primary central nervous system lymphoma
Trial Stage
Phase II
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
18-12-2024
First CTIS Authorization Date
20-12-2024

Trial design

open-label, arm 1 and 2: rituksimabi 375 mg/m2 d0; metotreksaatti 2500 mg/m2 i.a. d1-2; karboplatiini 200 mg/m2 i.a. d1-2; syklofosfamidi 330 mg/m2 i.v. d1-2; etoposidi 200 mg/m2 i.v. d1-2. arm 3: rituksimabi naisilla 375 mg/m2 ja miehillä 500 mg/m2 i.v. d0; metotreksaatti 1500 mg/m2 i.a. d1-2; karboplatiini 150 mg/m2 i.a. d1-2; syklofosfamidi 230 mg/m2 i.v. d1-2; etoposidi 150 mg/m2 i.v. d1-2.-controlled Phase II trial across 1 site in Finland.

Open Label
Yes
Comparator
Arm 1 and 2: Rituksimabi 375 mg/m2 d0; Metotreksaatti 2500 mg/m2 i.a. d1-2; Karboplatiini 200 mg/m2 i.a. d1-2; Syklofosfamidi 330 mg/m2 i.v. d1-2; Etoposidi 200 mg/m2 i.v. d1-2. Arm 3: Rituksimabi naisilla 375 mg/m2 ja miehillä 500 mg/m2 i.v. d0; Metotreksaatti 1500 mg/m2 i.a. d1-2; Karboplatiini 150 mg/m2 i.a. d1-2; Syklofosfamidi 230 mg/m2 i.v. d1-2; Etoposidi 150 mg/m2 i.v. d1-2.
Target Sample Size
100
Trial Duration For Participant
3650

Eligibility

Recruits 100 No vulnerable populations selected. Participants must be aged 18–75 and provide written informed consent. Patients with psychiatric illness or conditions preventing informed consent are explicitly excluded ("Potilaan psyykkinen sairaus tai taudista johtuva tilanne, joka estää häntä antamasta tietoista suostumusta tai sitoutumasta hoitoon"). No provision for assent or minor consent is stated..

Pregnancy Exclusion
13) Raskaus ja imetys
Vulnerable Population
No vulnerable populations selected. Participants must be aged 18–75 and provide written informed consent. Patients with psychiatric illness or conditions preventing informed consent are explicitly excluded ("Potilaan psyykkinen sairaus tai taudista johtuva tilanne, joka estää häntä antamasta tietoista suostumusta tai sitoutumasta hoitoon"). No provision for assent or minor consent is stated.

Inclusion criteria

  • {"criterion_text":"- 1) Potilaalla on primaarinen aivolymfooma, joko vasta todettu tauti tai laskimonsisäisen sytostaattiyhdistelmän jälkeen uusiutunut tai sille refraktaari tauti.\n- 2) Tauti edustaa histologialtaan diffuusia suurisoluista B-solulymfoomaa.\n- 3) Potilaan ikä on 18-70 vuotta haaroissa 1 ja 2 ja 71-75 vuotta haarassa 3.\n- 4) Potilas on antanut kirjallisen suostumuksen tutkimukseen osallistumisesta."}

Exclusion criteria

  • {"criterion_text":"- 1) Aiemmin annettu pään alueen sädehoito.\n- 3) Syvissä aivojen osissa sijaitseva lymfoomamuutos, joka turvotessaan voi aiheuttaa liquor-kierron häiriön.\n- 4) Potilaan psyykkinen sairaus tai taudista johtuva tilanne, joka estää häntä antamasta tietoista suostumusta tai sitoutumasta hoitoon.\n- 5) Maksan vajaatoiminta.\n- 6) Heikentynyt luuytimen toiminta.\n- 7) Vaikea munuaisten vajaatoiminta. Lievässä vajaatoiminnassa hoitoa voidaan antaa ilman metotreksaattia.\n- 8) Lääkityksen aikana oireinen sepelvaltimotauti.\n- 9) Sellainen lääkitys, joka tauottaa tai muuttaa turvalliseen 10) Muu yleissairaus, joka tukitoimien läpiviemisen 11) Muusta kuin aivolymfoomasta 12) Toinen malignooma hoitovaste.\n- 13) Raskaus ja imetys"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 2 ja 5 ja 10 vuoden seurannan kohdalla elossa olevien potilaiden suhteellinen lukumäärä primaari hoidossa olevilla ja uusiutunutta tautia sairastavilla potilailla.","definition_or_measurement_approach":"Proportion of patients alive at 2, 5 and 10 years post-treatment (relative number alive at those time points among patients with primary disease and those with relapsed disease)."}

Secondary endpoints

  • {"endpoint_text":"- Täydellisten ja osittaisten hoitovasteiden määrä 2 ja 5 ja 10 vuoden seurannan kohdalla tautivapaana olevien potilaiden suhteellinen lukumäärä Hoidon haittavaikutukset ja erityisesti pitkäaikaiset neurologiset haitat.","definition_or_measurement_approach":"Counts/proportions of complete and partial treatment responses assessed at 2, 5 and 10 years and recording of treatment-related adverse events, with emphasis on long-term neurological toxicities."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
227
Consent Approach
Written informed consent required from each participant. Inclusion criteria state: "Potilas on antanut kirjallisen suostumuksen tutkimukseen osallistumisesta." Participants are adults (18–75); no assent procedures for minors are provided. Patients unable to give informed consent (e.g. due to psychiatric illness) are excluded.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Finland

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
20-12-2024
Processing Time Days
66
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Oulu University Hospital
Department Name
Cancer Centre
Principal Investigator Name
Hanne Kuitunen
Principal Investigator Email
hanne.kuitunen@pohde.fi
Contact Person Name
Hanne Kuitunen
Contact Person Email
hanne.kuitunen@pohde.fi
Number Of Participants
100

Sponsor

Primary sponsor

Full Name
Oulu University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Etopofos 100 mg pulver till infusionsvätska, lösning
Active Substance
Etoposide phosphate
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Starting Dose
200 mg/m2 (Arm 1 and 2); 150 mg/m2 (Arm 3)
Dose Levels
200 mg/m2; 150 mg/m2
Frequency
d1-2
Maximum Dose
500 mg
Investigational Product Name
Karboplatin Accord 10 mg/ml koncentrat za otopinu za infuziju
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Starting Dose
200 mg/m2 (Arm 1 and 2); 150 mg/m2 (Arm 3)
Dose Levels
200 mg/m2; 150 mg/m2
Frequency
d1-2
Maximum Dose
500 mg
Investigational Product Name
Methotrexate Ebewe, 100 mg/ml, koncentrat till infusionsvätska, lösning
Active Substance
Methotrexate
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Starting Dose
2500 mg/m2 (Arm 1 and 2); 1500 mg/m2 (Arm 3)
Dose Levels
2500 mg/m2; 1500 mg/m2
Frequency
d1-2
Maximum Dose
6000 mg
Investigational Product Name
MabThera 100 mg concentrate for solution for infusion
Active Substance
Rituximab
Modality
Monoclonal antibody
Routes Of Administration
CONCENTRATE FOR SOLUTION FOR INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Starting Dose
375 mg/m2 (Arm 1 and 2; females in Arm 3); 500 mg/m2 (males in Arm 3)
Dose Levels
375 mg/m2; 500 mg/m2
Frequency
d0 (single infusion)
Maximum Dose
900 mg
Investigational Product Name
Sendoxan 2 000 mg injektiokuiva-aine, liuosta varten
Active Substance
Cyclophosphamide
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INJECTION
Route
Intravenous injection/infusion
Authorisation Status
Authorised
Starting Dose
330 mg/m2 (Arm 1 and 2); 230 mg/m2 (Arm 3)
Dose Levels
330 mg/m2; 230 mg/m2
Frequency
d1-2
Maximum Dose
800 mg
Combination Treatment
Yes

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