Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT02488512
Status:
TERMINATED
Last Update Posted:
2018-03-19
First Post:
2015-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell and Mantle Cell Lymphomas
Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Organization:
Study Overview
Official Title:
Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell (DLBCL) and Mantle Cell Lymphomas (MCL)
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
critical low recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
itTRIOlym
Brief Summary:
This is a prospective, single arm,single centre open-label, phase II study in relapsed or refractory DLBCL and MCL non-Hodgkin's lymphoma (NHL), not suitable to other therapies, included HDCT, or patients relapsed after high-dose chemotherapy (HDCT) with autologous stem-cell transplantation (ASCT), treated with peptide receptor radionuclide therapy with 90Y-Dotatoc.
Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi), divided into 4 cycles (1.8 - 2.8 gigabequerel (GBq) for each cycle) with an interval of 6 - 8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.
35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed).
Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi), divided into 4 cycles (1.8 - 2.8 gigabequerel (GBq) for each cycle) with an interval of 6 - 8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.
35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed).
Detailed Description:
PEPTIDE RECEPTOR RADIONUCLIDE THERAPY (PRRT) WITH 90Y-DOTATOC IN RELAPSED/REFRACTORY DIFFUSE LARGE B CELL AND MANTLE CELL LYMPHOMAS.
This is a prospective, single arm, open-label, phase II study. It is estimated that a maximum of 35 patients will be enrolled in 36 months; the treatment efficacy will be tested in 18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed; if \> 2 objective responses will be observed, a total of 35 patients will be enrolled.
Follow up period is 48 months.
Single-center
The primary objective is the evaluation of objective response rate (ORR). of Y-PRRT in relapsed or refractory DLBCl and MCL NHL, not suitable to other therapies, included HDCT, or patients relapsed after HDCT with ASCT.
The secondary objectives are toxicity (acute and late), progression free survival, overall survival and Quality of life.
35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed).
Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi), divided into 4 cycles (1.8 - 2.8 GBq for each cycle) with an interval of 6 - 8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.
The study will be conducted following the Optimal Two Stage Design assuming the true response probability:
* under H0 (p0) \<=10%
* under H1 (p1) \>=30% and considering alpha=0.05 and power=0.90.
This is a prospective, single arm, open-label, phase II study. It is estimated that a maximum of 35 patients will be enrolled in 36 months; the treatment efficacy will be tested in 18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed; if \> 2 objective responses will be observed, a total of 35 patients will be enrolled.
Follow up period is 48 months.
Single-center
The primary objective is the evaluation of objective response rate (ORR). of Y-PRRT in relapsed or refractory DLBCl and MCL NHL, not suitable to other therapies, included HDCT, or patients relapsed after HDCT with ASCT.
The secondary objectives are toxicity (acute and late), progression free survival, overall survival and Quality of life.
35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed).
Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi), divided into 4 cycles (1.8 - 2.8 GBq for each cycle) with an interval of 6 - 8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.
The study will be conducted following the Optimal Two Stage Design assuming the true response probability:
* under H0 (p0) \<=10%
* under H1 (p1) \>=30% and considering alpha=0.05 and power=0.90.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: