Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Seagen Inc.
- Study ID
- NCT02855359
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Diffuse, Large B-Cell, Lymphoma
- Follicular Lymphoma, Grade 3b
- Transformed Lymphoma / DLBCL
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- denintuzumab mafodotin — DRUGSGN-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
- rituximab — DRUG375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
- cyclophosphamide — DRUG750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
- doxorubicin — DRUG50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
- vincristine — DRUG1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
- prednisone — DRUG100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Study Details
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.
Key Dates
- Start date
- Aug 31, 2016
- Status verified
- Feb 2019
- Primary completion
- Jan 31, 2018
- Completion
- May 15, 2018
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: denintuzumab mafodotin + RCHOPPart A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
- Experimental: denintuzumab mafodotin + RCHPPart A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
- Experimental: denintuzumab mafodotin + RCHOP or RCHPPart B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
- Active Comparator: RCHOPPart B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Primary Outcome Measure
Part B Outcome Measure: Complete Response Rate (CR) [ Time Frame: N/A - Endpoint not assessed ]
Locations (34)
Find similar trials in Birmingham, AL
By research site
University of Alabama at Birmingham· Birmingham, ALSaint Bernards Cancer Center· Jonesboro, ARCity of Hope· Duarte, CACompassionate Cancer Care Medical Group, Inc.· Fountain Valley, CAPacific Hematology Oncology Associates· San Francisco, CAUniversity of Colorado Health Memorial Hospital· Colorado Springs, CO