Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132737
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-11-06
Brief Title:
90YY-PTT Endoradiotherapy in CNS Lymphoma Patients
Sponsor:
Pentixapharm AG
Organization:
Pentixapharm AG
Study Overview
Official Title:
An Open-label Dose Escalation Study to Evaluate Safety Tolerability Biodistribution and Efficacy of 90YY-PentixaTher for the Therapy of Recurrent or Refractory Primary or Isolated Secondary Central Nervous System Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be an open-label single-arm national phase 12 therapeutic study to evaluate the safety tolerability and preliminary efficacy of 90YY-PentixaTher 90YY-PTT for the treatment of recurrent or refractory primary or isolated secondary central nervous system CNS lymphoma
The study will be performed in three cohorts with different dose levels according to the best-of-5 dose escalation design A safety review committee SRC will evaluate dose-limiting toxicities and decide about escalation and de-escalation
Eligible patients will receive one cycle of 90YY-PTT which will be administered intravenously There will be no comparator in this study
Safety biodistribution dosimetry and efficacy will be evaluated during the core study phase Visit 1 until Visit 5 Thereafter three follow-up FU visits will take place at three-months intervals to evaluate the extent of disease
The study will be performed in three cohorts with different dose levels according to the best-of-5 dose escalation design A safety review committee SRC will evaluate dose-limiting toxicities and decide about escalation and de-escalation
Eligible patients will receive one cycle of 90YY-PTT which will be administered intravenously There will be no comparator in this study
Safety biodistribution dosimetry and efficacy will be evaluated during the core study phase Visit 1 until Visit 5 Thereafter three follow-up FU visits will take place at three-months intervals to evaluate the extent of disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None