Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Condition: Lymphoma, B-cell; Lymphoma, Large B-cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: brentuximab vedotin; brentuximab vedotin; rituximab; vincristine; cyclophosphamide; prednisone; doxorubicin
Intervention description: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles; 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles; 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles; 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total); 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles; 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles; 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Brentuximab Vedotin; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Drug Therapy; Hematologic Diseases; Lymphoma, B-cell; Lymphoma, Large B-cell, Diffuse; Monomethyl auristatin E

Summary:

      This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and
      efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide,
      doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have
      never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP
      together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is
      a difference in side effects between the 2 groups.

      The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab
      vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
      (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients
      will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.

      The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared
      to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients
      will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be
      tested to see if there is a difference in side effects between the 2 groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-naive patients with systemic de novo or transformed diffuse large B cell
             lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b

          -  International Prognostic Index (IPI) score greater than or equal to 3 for patients
             greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients
             less than or equal to 60 years of age

          -  Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease

          -  Measurable disease of at least 1.5 cm

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

          -  Patients in Parts 2 and 3 must have histologically confirmed diagnosis of
             CD30-positive DLBCL

        Exclusion Criteria:

          -  Previous history of treated indolent lymphoma

          -  History of another primary malignancy that has not been in remission for 3 years