A Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GemOx) Versus R-GemOx Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- MedDRA version: 21.1Level: LLTClassification code 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractorySystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]Relapsed/refractory diffuse large B-cell lymphoma (DLBL)MedDRA version: 21.1Level: LLTClassification code 10012856Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrentSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864
- Registration Number
- EUCTR2018-003727-10-SE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 216
- Age >= 18 years
- Ability to comply with the study protocol, in the investigator’s judgment
- Histologically-confirmed DLBCL, not otherwise specified or history of transformation of indolent disease to DLBCL
- Relapsed or refractory disease
- At least one (>= 1) line of prior systemic therapy
- At least one bi-dimensionally measurable lesion
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- Adequate hematological function
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 12 months after the final dose of pola or rituximab
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm, with a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the final dose of oxand/or gem
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Contraindication to R, gem or ox
- Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0 at enrollment
- Prior use of pola or a gem + platinum-based agent combination
- Enrollment in any previous or ongoing pola trial
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
- Planned autologous or allogeneic stem cell transplantation at time of recruitment
- Primary or secondary central nervous system lymphoma at the time of recruitment
- Richter’s transformation or prior chronic lymphocytic leukemia
- Any of the following abnormal laboratory values, unless abnormal laboratory values are due to underlying lymphoma per the investigator:
o Creatinine > 1.5 x upper limit of normal (ULN) or a measured creatinine clearance < 30 mL/min
o Aspartate aminotransferase or alanine aminotransferase > 2.5 x ULN
o Total bilirubin >= 1.5 x ULN. Patients with documented Gilbert disease may be enrolled if total bilirubin is <= 3 x ULN
o International normalized ratio or prothrombin time > 1.5 x ULN in the absence of therapeutic anticoagulation
o Partial thromboplastin time or activated partial thromboplastin time > 1.5 x ULN in the absence of a lupus anticoagulant
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or significant pulmonary disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to Cycle 1 Day 1
- Patients with suspected or latent tuberculosis
- Positive test results for chronic hepatitis B virus infection and hepatitis C virus antibody
- Known history of human immunodeficiency virus seropositive status
- Vaccination with a live vaccine within 4 weeks prior to treatment
- Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method