CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL), grade 3 follicular lymphoma (FL) and mantle cell lymphoma (MCL). MedDRA version: 12.0 Level: HLT Classification code 10029592 Term: Non-Hodgkin's lymphomas NEC
Conditions
Sponsors
Astellas Pharma Global Development, Inc. (APGD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject is eligible for the study if all of the following apply: 1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). 2. Male or female subject aged 18 years or older at the Baseline Visit. 3. Any stage, histologically confirmed CD20-positive primary or transformed DLBCL, grade 3 FL or MCL. 4. Ineligible for or have previously received an ASCT. 5. Relapsed following receipt of last dose of systemic chemotherapy or ASCT. o Relapsed = Completed systemic chemotherapy or ASCT exhibiting at least a PR that was maintained for at least 6 months following completion of the treatment. 6. At least one, but no more than 3 prior chemotherapy regimens, including one anthracycline-based combination regimen. o Any planned maintenance therapy should be considered as part of the previous treatment regimen. o Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the ASCT as one treatment regimen. 7. Eastern Cooperative Oncology Group (ECOG) performance status = 1 at the Baseline Visit. 8. Life expectancy greater than 12 weeks at the Baseline Visit. 9. At least one measurable lesion = or equal to 1.5 cm in the longest transverse diameter as assessed via Screening Period computed tomography (CT) scan. 10. The subject with a previous history of non-CD20+ B cell NHL malignancy is eligible for this study only if the subject meets the following criteria for a cancer survivor: o Subject having basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix is eligible if he/she has had potentially curative treatment anytime prior to enrollment. o The subject has undergone potentially curative therapy for all prior malignancies, and the subject has been considered disease free for at least 5 years. 11. If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception (double barrier) throughout the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will be excluded from participation if any of the following apply: 1. Use of any standard/experimental anti-lymphoma drug therapy, within 21 days of the Baseline Visit. 2. Use of systemic steroids within 5 days of the Baseline Visit. o A subject receiving steroids at the time of the Baseline Visit is eligible as long as the subject is receiving a biologic dose or has been on a stable, non-biologic dose for at least 4 weeks prior to the first dose of YM155 and plans on continuing to receive the stable, non-biologic dose during study participation. 3. Prior allogeneic stem cell transplant (SCT). 4. Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as: o Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated serum creatinine clearance < 60 mL/min. o Absolute neutrophil count (ANC) = 1000/mm3. o Platelet = 100,000/mm3. o Alanine transaminase (ALT) and Aspartate transaminase (AST) = 2.5 x ULN or = 5 x ULN if secondary to liver metastases. 5. Central nervous system (CNS) or leptomeningeal involvement by lymphoma as determined by the Investigator through physical examination and medical history review at the Baseline Visit. 6. The subject has significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions at the Baseline Visit that in the Investigator’s judgment would jeopardize subject enrollment or compliance with the study procedures. 7. The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody. 8. The subject has been previously treated with YM155. 9. The subject has received other investigational therapy or procedures within 28 days prior to the first study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine objective response rate (ORR) (complete remission [CR] + partial remission [PR]) per [the International Working Group (IWG) Revised Response Criteria for Malignant Lymphomas (2007)].;Secondary Objective: To evaluate the following: • Safety and tolerability of YM155 given in combination with rituximab. • CR Rate. • PR Rate. • Time to response. • Duration of response. • Clinical benefit rate (CBR). • Progression-free survival (PFS). • Overall survival (OS).;Primary end point(s): The primary endpoint for this study is the objective response rate (ORR). The ORR is defined as the proportion of subjects with CR or PR assessed by independent third party reviewer during the study per the International Working Group (IWG) Revised Response Criteria for Malignant Lymphomas (2007). | — |
Countries
France, Spain, United Kingdom
Outcome results
None listed