Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell and Mantle Cell Lymphomas

NCT02488512 | Terminated Phase 2

• 1 other identifier: IRST202.02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

DLBCL; MCL; Recurrent Disease

Keywords

Relapsed/refractory diffuse large b cell; Relapsed/refractory mantle cell lymphomas; DLBCL; MCL; 90Y-DOTATOC; SSR-positive tumour

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

  ORR will be calculated according to Response Evaluation Criteria in Non Hodgkin's lymphoma according to Cheson Criteria

  up to 48 months

Secondary Outcomes (5)

• acute toxicity evaluation

  up to 48 months

• progression free survival (PFS)

  up to 48 months

• overall survival (OS)

  up to 48 months

• Quality of Life (QLQ)

  up to 48 months

• late toxicity evaluation

  up to 48 months

Study Arms (1)

90Y-DOTATOC

EXPERIMENTAL

90Y-DOTATOC

Drug: 90Y-DOTATOC

Interventions

90Y-DOTATOC DRUG

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.

Also known as: Y-PRRT

90Y-DOTATOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, aged \>18 years.
• Histologically confirmed relapsed or refractory DLBCL or MCL not suitable to other treatments.
• 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).
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Life expectancy of at least 3 months.
• Adequate cardiac function as assessed at echocardiography and ECG.
• 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), Alanine aminotransferase (ALT) \<2.5 X UNL (\< 5 X UNL in presence of liver metastases), creatinine \< 2 mg/dL
• Patients must not have received other treatments with radiopeptides (e.g. 111In-pentetreotide, 177Lu-DOTATATE, 131I-MIBG).
• If female of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at screening visit and continuing until 3 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 7 days of starting treatment.

You may not qualify if:

• Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory).
• Bone marrow invasion \> 25 %.
• 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).
• Evidence of myelodysplastic syndrome or other hematologic diseases
• Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks.
• Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
• 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.
• Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HbsAg). In addition, if negative for HBsAg but Hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a hepatitis B virus (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.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition.
• Previous autologous stem cell transplant in the last 2 months.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

Nuclear Medicin Division, IRST IRCCS

Meldola, FC, 47014, Italy

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, Mantle-Cell

Interventions

90Y-octreotide, DOTA-Tyr(3)-

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maddalena Sansovini, MD

  IRST IRCCS, Meldola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: July 2, 2015
• Study Start: December 22, 2016
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

IT (1)