Relapsed or refractory DLBCL (DIFFUSE LARGE B CELL LYMPHOMAS) or MCL (MANTLE CELL LYMPHOMAS) MedDRA version: 17.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0 Level: HLT Classification code 10026798 Term: Mantle cell lymphomas System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: [90Y–DOTA0-Tyr3]-Octreotide (90Y-DOTATOC)
Product Code: NA
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: 90Y-DO
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female, aged >18 years. 2 . Histologically confirmed relapsed or refractory DLBCL or MCL not suitable to other treatments. 3. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT with 68Ga-DOTATOC images demonstrate a significant uptake in the tumour (SSR-positive tumour). 4. Patients must have at least one bidimensional measurable lesion with long axis > 15 mm at CT scan (MRI is allowed only if CT scan cannot be performed), according to Cheson Criteria [48]. 5. ECOG performance status = 2. 6. Life expectancy of at least 3 months. 7. Adequate cardiac function (EF >50%) as assessed at echocardiography and ECG. 8. Conserved hematological, liver and renal parameters, and in particular: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin =1.5 X UNL (upper normal limit), ALT =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1. Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory). 2. Bone marrow invasion > 25 %. 3. Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers); subjects must be free from other neoplasms at least 3 years. All acute toxic effects of any prior therapy (including surgery radiation therapy,chemotherapy) must have resolved to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE). 4. Evidence of myelodysplastic syndrome or other hematologic diseases 5. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks. 6. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8. Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HbsAg). In addition, if negative for HBsAg but Hepatits B core antibody (HBcAb) positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded. Any patient with HBcAb positivity will receive anti viral prophylaxis during the study, according to the procedures suggested by local Hepatology service. 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition. 10. Previous autologous stem cell transplant in the last 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the overall response rate of Y-PRRT in relapsed or refractory DLBC and MCL NHL, not suitable to other therapies, included HDCT (high dose chemotherapy), or patients relapsed after HDCT with ASCT (Autologous stem cell transplant).;Secondary Objective: The secondary objectives are acute and late toxicity, the type and duration of lymphocyte toxicity, (B, T, NK lymphocytes), progression free survival, overall survival and Quality of Life. ;Primary end point(s): overall response rate of Y-PRRT in relapsed or refractory DLBC and MCL NHL, not suitable to other therapies, included HDCT (high dose chemotherapy), or patients relapsed after HDCT with ASCT (Autologous stem cell transplant).;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Acute and late toxicity, the type and duration of lymphocyte toxicity, (B, T, NK lymphocytes), progression free survival, overall survival and Quality of Life;Timepoint(s) of evaluation of this end point: 12-48 months | — |
Countries
Italy
Contacts
Public ContactCentro di Coordinamento Studi IRST
IRST IRCCS
Outcome results
None listed