Clinical Trial Search

Primary: Overall Response (OR) Rate — 0.07 Proportion of participants

Primary: Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) — 0; 0; 0; 0…

Primary: Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment — 0.69; 0.53 proportion

Primary: Complete Remission — 10 participants

Primary: Progression-free Survival — 89 percentage of participants

Primary: 2-year Overall Survival Rates — 71.1; 73.7 percentage of participants

Primary: Progression-free Survival (PFS) — 18 participants

Primary: Number of Participants With Objective Response — 1; 2; 14; 6 Participants

Primary: Overall Response (Complete Response + Partial Response) — 216; 94 Participants

Primary: 2-year Progression-Free Survival (PFS) — 0.76; 0.42 probability

Primary: 1 Year Progression-free Survival Rate — 0.74 percentage of participants

Primary: Progression-Free Survival Rate at 2 and 5 Years — 78.9; 75.5; 68.0; 66.0 percentage of participants — p=0.6519

Primary: Participants Categorized by Best Response as Determined by Central Review — 7; 21; 40; 71 Participants

Primary: Overall Survival — 0; 0 Proportion of participants

Primary: Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment — 52 percentage of participants analyzed

Primary: Assessment of Tumor Response — 30.3; 54.5 percentage of participants

Primary: Progression-free Survival at 2 Years — 76; 80 percentage of participants — p=0.11

Primary: ORR Assess by IRC — 76.0 percentage

Primary: Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. — 2; 3; 4; 5 mg/m2

Primary: Percentage of Participants With 3-year Progression-free Survival (PFS) — 90 percentage of participants

Primary: Response Rate — 29 percentage of participants

Primary: Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status — 0.21 proportion of CR or PR patients

Primary: Percentage of Patients With Complete Response to the Combination Chemotherapy — 75.0; 23.0 Percentage of participants

Primary: Number of Participants in Complete Remission 6 Months After Randomization — 14; 9 Participants

Primary: Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response) — 0.48 proportion of participants

Primary: 2-year PFS From the Start of Induction Therapy Conditional — 86.6; 90.6; 0.4 percentage of patients

Primary: Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase — 0; 0; 0 Participants

Primary: Progression-free Survival (PFS) at 2 Years — 69 percentage of participants

Primary: Time to Rituximab Failure (TTRF) — 3.92; 4.32; 1.39; 4.83 years — p=0.33

Primary: Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment — 3.0; 3.0 months — p== 0.694