Trials / Terminated
TerminatedNCT02592876
Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma
A Randomized, Open-Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) Plus Rituximab, Ifosfamide, Carboplatin, and Etoposide (19A+RICE) Chemotherapy vs. RICE in the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Who Are Candidates for Autologous Stem Cell Transplant
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this randomized, open-label study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1 ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or RICE alone. The study will assess whether there is a difference between the 2 groups in the side effects that are reported and the number of patients who achieve complete remission at the end of their study treatment.
Conditions
- Lymphoma, B-cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Follicular, Grade 3b
- Follicular Lymphoma, Grade 3b
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | denintuzumab mafodotin | Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles. |
| DRUG | rituximab | 375 mg/m\^2 by IV infusion, every 3 weeks for up to 3 cycles |
| DRUG | ifosfamide | 5000 mg/m\^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles |
| DRUG | carboplatin | AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles |
| DRUG | etoposide | 100 mg/m\^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2018-04-20
- Completion
- 2018-04-20
- First posted
- 2015-10-30
- Last updated
- 2019-05-17
- Results posted
- 2019-05-17
Locations
29 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02592876. Inclusion in this directory is not an endorsement.