Diffuse large B-cell Lymphoma refractory MedDRA version: 9.1 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory
Conditions
Interventions
Product Name: YM155
Product Code: YM155
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: YM155
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Astellas Pharma US, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects aged 18 years or older. - Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) (including transformed DLBCL) of any stage. - Refractory to the last treatment regimen, defined as one of the following: o The subject failed to obtain at least a Partial Remission (PR) at anytime while receiving the previous treatment regimen. o The subject obtained at least a PR during the previous treatment regimen, but later progressed while still on the treatment regimen. o The subject obtained at least a PR to the previous treatment regimen, but progressed within 6 months following completion of the previous treatment regimen. - Subjects who have not received an autologous Bone Marrow Tansplant (BMT) or autologous Peripheral Blood Stem Cell Transplant (PBSCT) must have refused or been ineligible for that procedure. - At least one measurable lesion defined as superior or equal to 1.5 cm in the longest transverse diameter by CT scan. - No known central nervous system involvement. - Eastern Cooperative Oncology Group (ECOG) performance status inferior or equal to 2. 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: - Any therapy for lymphoma within 21 days prior to the first YM155 dose. - Within 4 weeks of the baseline FDG-PET scan, subjects cannot have had the following: o Radiation therapy. o Surgical procedures (except biopsies and central catheter / port placement). o Active infection (bloodstream or deep tissue). - Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as: o Serum creatinine superior or equal to 1.5 x Upper Limit of Normal (ULN) or calculated serum creatinine clearance 3 prior treatment regimens for their lymphoma. Subjects are permitted to have had an autologous BMT or autologous PBSCT as one of the prior treatment regimens. If a subject has had an autologous BMT or autologous PBSCT, it, along with any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) is included as one treatment regimen. - Allogeneic BMT or allogeneic PBSCT. - History of other malignancy requiring treatment within 5 years, except for treated basal or squamous cell carcinoma of the skin or in situ cervical cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall response rate (Complete Remission + Partial Remission) of YM155 per the International Working Group Criteria (IWG, 2007) during 15 cycles of treatment.;Secondary Objective: To evaluate the efficacy, safety and tolerability of YM155 during 15 cycles of treatment.;Primary end point(s): Overall response rate (Complete Remission + Partial Remission) per the International Working Group Criteria (IWG, 2007) | — |
Countries
France, Spain, United Kingdom
Outcome results
None listed