EUCTR2014-001361-28-ES
Active, not recruiting
Not Applicable
A Phase Ib/II study evaluating the safety, tolerability and anti-tumor activity of polatuzumab vedotin (DCDS4501A) in combination with rituximab (R) or obinutuzumab (G) plus bendamustine (B) in relapsed or refractory follicular or diffuse large B-cell lymphoma
Roche Farma S.A., que representa en España a F.Hoffmann-La Roche0 sites224 target enrollmentOctober 13, 2015
ConditionsFollicular Lymphoma and Diffuse Large B-Cell LymphomaMedDRA version: 18.1Level: LLTClassification code 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractorySystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10012856Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
- Sponsor
- Roche Farma S.A., que representa en España a F.Hoffmann-La Roche
- Enrollment
- 224
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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 dose of study drug
Exclusion Criteria
- •\- 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 half\-lives 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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