A Study Evaluating the Safety, Tolerability and Anti-tumor Activity of Polatuzumab Vedotin (pola) in combination with Rituximab (R) or Obinutuzumab(G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or DiffuseLarge B-Cell Lymphoma
- Conditions
- Follicular Lymphoma and Diffuse Large B-Cell LymphomaMedDRA version: 21.1Level: LLTClassification code 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractorySystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10012856Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001361-28-IT
- Lead Sponsor
- F. HOFFMANN - LA ROCHE LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 331
- Age >= 18 years
- Histologically confirmed FL (Grade 1, 2, or 3a) or DLBCL
- Must have received at least one prior therapy for FL or DLBCL. Patients must have either relapsed or have become refractory to a prior regimen
as defined in the protocol.
- If the patient has received prior bendamustine, response duration must have been > 1 year (for patients who have relapse disease after a
prior regimen)
- At least one bi-dimensionally measurable lesion on imaging scan defined as > 1.5 cm in its longest dimension
- Confirmed availability of archival or freshly collected tumor tissue prior to study enrollment
- Life expectancy of at least 24 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate hematologic function unless inadequate function is due to underlying disease.
- For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea and age >45 years) or surgically sterile:
agreement to remain abstinent or to use single highly effective or combined contraceptive methods that result in a failure rate of <1% per
year during the treatment period and for >=12 months after the last obinutuzumab, and agreement to refrain from donating eggs
- For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing.
- For men, agreement to remain abstinent or to 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 at least 5 months after the last dose of study drug and agreement to refrain from donating sperm during this same period
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 134
- History of severe allergic or anaphylactic reactions to humanized or murine MAbs (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Contraindication to bendamustine, rituximab, or obinutuzumab
- History of sensitivity to mannitol (mannitol is an excipient in bendamustine)
- Prior use of any MAb, radioimmunoconjugate, or ADC within 5 halflives or 4 weeks (whichever is longer) of study start before Cycle 1 Day 1
- 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
- Ongoing corticosteroid use >30 mg/day prednisone or equivalent, for purposes other than lymphoma symptom control
-Treatment with chimeric antigen receptor T-cell therapy within 100 days prior to Cycle 1 Day 1
- Completion of autologous stem cell transplant within 100 days prior to
Cycle 1 Day 1
- Prior allogeneic stem cell transplant
- Eligibility for autologous SCT (patients with R/R DLBCL)
- Grade 3b follicular lymphoma
- History of transformation of indolent disease to DLBCL
- Primary or secondary CNS lymphoma
- Current Grade >1 peripheral neuropathy
- 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 requiring
treatment with intravenous (IV) antibiotics or hospitalization within 4
weeks prior to Cycle 1 Day 1
- Patients with suspected or latent tuberculosis,
- Positive test results for chronic hepatitis B virus infection or for
hepatitis C virus antibody
- Known infection with HIV or human T-cell leukemia virus 1 virus
- Vaccination with a live vaccine within 28 days prior to treatment
- Recent major surgery (within 6 weeks before the start of Cycle 1 Day
1) other than for diagnosis
- Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of rituximab or obinutuzumab
- Any abnormal laboratory values as defined in the protocol, unless abnormal laboratory values are due to underlying lymphoma per the investigator
- 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
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