Non Hodgkin Lymphoma Clinical Trial
Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy.
In March 2019, decision made to not proceed with phase 3.
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with R/R aggressive B-NHL not achieving CMR after standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to IC chemotherapy.The phase 2 component of the study will consist of up to a 28-day screening period, approximately 70 to 112 days of study treatment, a 30-day (+/- 3days) safety follow up, and long-term follow up that will conclude with the final analysis of the phase 3 component, estimated at 30 months after initiation of the phase 3 component. For the phase 3 component, the study will consist of up to a 28-day screening period, a treatment period of up to approximately 168 days, a 30-day safety follow-up visit, and long-term follow up. Long-term follow up will conclude with the final analysis.In the phase 2 component, enrolled subjects will receive blinatumomab monotherapy. In the phase 3 component, enrolled subjects will be randomized in a 1:1 ratio to blinatumomab or IC chemotherapy.
In March 2019, decision made to not proceed with phase 3.
Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible:
Mantle cell lymphoma Any histologies not specifically mentioned must be discussed with medical monitor.
Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
Biopsy proven confirmation of relapsed disease.
Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
Radiographically measurable disease with a demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
Eastern Cooperative Oncology Group performance status less than or equal to 2
Intention to proceed to high dose chemotherapy (HDT) and autologous hematopoietic stem cell transplant (HSCT)
Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
Platelets ≥ 75 x 10^9/L
Creatinine clearance ≥ 50 mL/min
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)
CMR following S1 chemotherapy
Treatment within 30 days prior to randomization with another investigational device or drug study (ies).
Prior anti-CD19-directed therapies
Prior HDT with autologous HSCT
Prior allogeneic HSCT
Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Evidence of CNS involvement by NHL
Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti hepatitis C virus positive)
History of malignancy other than B-NHL within the past 3 years with the exception of:
Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment
Adequately treated non-melanoma skin cancer or lentigo maligna
Adequately treated cervical carcinoma in situ
Adequately treated breast ductal carcinoma in situ
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
Known sensitivity to immunoglobulins or any of the components to be administered during dosing.
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures.
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed, or of childbearing potential unwilling to use an effective method of contraception while receiving, and for an additional 48 hours after the last dose of blinatumomab.
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There are 31 Locations for this study
Duarte California, 91010, United States
Baltimore Maryland, 21201, United States
Oklahoma City Oklahoma, 73104, United States
Greenville South Carolina, 29607, United States
St Leonards New South Wales, 2065, Australia
Herston Queensland, 4029, Australia
Melbourne Victoria, 3004, Australia
Parkville Victoria, 3052, Australia
Murdoch Western Australia, 6150, Australia
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Montreal Quebec, H1T 2, Canada
Bergamo , 24127, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Palermo , 90146, Italy
Pisa , 56100, Italy
Roma , 00161, Italy
Udine , 33100, Italy
San Juan , 00918, Puerto Rico
Cordoba Andalucía, 14004, Spain
Valladolid Castilla León, 47012, Spain
Barcelona Cataluña, 08025, Spain
Santiago de Compostela Galicia, 15706, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Murcia , 30008, Spain
Bristol , BS2 8, United Kingdom
Nottingham , NG5 1, United Kingdom
Sheffield , S10 2, United Kingdom
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