Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Seagen Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Treatment Details

Interventions

• Denintuzumab Mafodotin (Monoclonal Antibodies)

Participant Groups

Group I: denintuzumab mafodotin + RCHP Experimental Treatment 5 Interventions

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)

Group II: denintuzumab mafodotin + RCHOP or RCHP Experimental Treatment 6 Interventions

Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP

Group III: denintuzumab mafodotin + RCHOP Experimental Treatment 6 Interventions

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Group IV: RCHOP Active Control 5 Interventions

Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Medical Center Pittsburgh, PA

Loyola University Medical Center Maywood, IL

Virginia Piper Cancer Institute Minneapolis, MN

Research Medical Center Kansas City, MO

More Trial Locations

Who Is Running the Clinical Trial?

Seagen Inc. Lead Sponsor

References