Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Condition: Diffuse, Large B-Cell, Lymphoma; Follicular Lymphoma, Grade 3b; Transformed Lymphoma / DLBCL
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Intervention: denintuzumab mafodotin; rituximab; cyclophosphamide; doxorubicin; vincristine; prednisone
Intervention description: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles; 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles; 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles; 50 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); 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies, Monoclonal; SGN-19A; Denintuzumab Mafodotin; DLBCL; Antibody-Drug Conjugate; Antigens, CD19; Hematologic Diseases; Immune System Diseases; Immunoproliferative Disorders; Immunotherapy; Lymphatic Diseases; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Monomethyl auristatin F; Neoplasms; Neoplasms by Histologic Type; Transformed Lymphoma / DLBCL; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine; Alkylating Agents; Anti-Inflammatory Agents; Antibiotic, Antineoplastic; Antimitotic Agents; Antineoplastic Agents, Alkylating; Antineoplastic Agents; Phytogenic Antirheumatic Agents; Glucocorticoids; Drug Therapy; Follicular Lymphoma Grade 3b; immunosuppressive agents

Summary:

      This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination
      with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse
      large B-cell lymphoma or follicular lymphoma Grade 3b.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment-naive patients with histologically confirmed systemic de novo or transformed
             diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or
             follicular lymphoma (FL) Grade 3b;

               -  patients must have high intermediate or high risk disease

          -  Tumor tissue available from most recent biopsy to determine cell of origin

          -  Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease
             greater than 1.5cm diameter

          -  Eastern Cooperative Oncology Group performance status ≤2

          -  Age 18 years or older

          -  Adequate study baseline laboratory parameters

        Exclusion Criteria:

          -  Previous history of treated indolent lymphoma

          -  History of another primary invasive cancer, hematologic malignancy, or myelodysplastic
             syndrome that has not been in remission for at least 3 years

          -  History of progressive multifocal leukoencephalopathy

          -  Cerebral/meningeal disease related to the underlying malignancy

          -  Patients with the following ocular conditions: corneal disorders, monocular vision
             (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or
             active ocular disorders requiring treatment