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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi) \[45-46\], divided into 4 cycles (1.8 - 2.8 GBq for each cycle) with an interval of 6 - 8 weeks between cycles. The activity to be administered will be measured in a dose calibrator, properly calibrated for the 90Y-radionuclide.
Nuclear Medicin Division, IRST IRCCS
Meldola, FC, Italy
overall response rate (ORR)
ORR will be calculated according to Response Evaluation Criteria in Non Hodgkin's lymphoma according to Cheson Criteria
Time frame: up to 48 months
acute toxicity evaluation
The acute toxicity will be recorded according to the CTC-AE, version 4.0 in the safety population until Follow-up is completed (48 months).
Time frame: up to 48 months
progression free survival (PFS)
PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation
Time frame: up to 48 months
overall survival (OS)
OS is defined as the time from treatment start to the time of death from any cause. Subjects who are alive at the time of the final analysis or who have become lost to follow-up will be censored at their last known alive date.
Time frame: up to 48 months
Quality of Life (QLQ)
Quality of life will be evaluated with Version 3.0 European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Time frame: up to 48 months
late toxicity evaluation
The late toxicity will be recorded according to the CTC-AE, version 4.0 in the safety population until Follow-up is completed (48 months) .
Time frame: up to 48 months
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