Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma

Browse trials for

• Lymphoma 5,578
• Lymphoma, Follicular 931
• Lymphoma, B-Cell 1,411
• Lymphoma, Large B-Cell, Diffuse 1,390

Keywords

• Antibodies, Monoclonal
• Antibody-Drug Conjugate
• Antigens, CD19
• Autologous Stem Cell Transplant
• Drug Therapy
• Follicular Lymphoma Grade 3b
• Hematologic Diseases
• Immune System Diseases
• Immunoproliferative Disorders
• Immunotherapy
• Lymphatic Diseases
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Monomethylauristatin F
• Neoplasms
• Neoplasms by Histologic Type
• Transformed Lymphoma / DLBCL
• Rituximab
• Ifosfamide
• Carboplatin
• Etoposide

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 81 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Lead sponsor

Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.

Study arms

• Experimental
  19A+RICE

  Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide

  Drug: denintuzumab mafodotin · Drug: rituximab · Drug: ifosfamide · Drug: carboplatin · Drug: etoposide

• Active comparator
  RICE

  Rituximab, ifosfamide, carboplatin, and etoposide

  Drug: rituximab · Drug: ifosfamide · Drug: carboplatin · Drug: etoposide

Interventions

• Drugdenintuzumab mafodotin

  Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.

  Also known as: SGN-CD19A

• Drugrituximab

  375 mg/m\^2 by IV infusion, every 3 weeks for up to 3 cycles

• Drugifosfamide

  5000 mg/m\^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles

• Drugcarboplatin

  AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles

• Drugetoposide

  100 mg/m\^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles

Primary outcomes

1. Complete Remission Rate Per Independent Review Facility

   Number of patients with complete metabolic response by PET (positive emission tomography) and CT (computed tomography) scans, or complete radiologic response by CT only.

   Time frame: Up to 4 months

Secondary outcomes

1. Number of Participants With Adverse Events (AEs)

   Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. AE severity and seriousness are assessed independently. 'Severity' characterizes the intensity of an AE and is graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. An AE is considered 'serious' if it is life-threatening, fatal, requires hospitalization, or is otherwise considered to be medically significant.

   Time frame: Up to 4 months

2. Number of Participants With Laboratory Abnormalities

   Number of participants who experienced a maximum post-baseline laboratory toxicity of Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03).

   Time frame: Up to 4 months

3. Objective Response Rate (ORR)

   ORR is defined as the proportion of patients with complete remission (CR) or partial remission (PR) per independent review facility (IRF) at the end of treatment.

   Time frame: Up to 4 months

4. Duration of Complete Response (CR)

   Defined as the time from the start of the first radiographic documentation of CR per investigator to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

   Time frame: Up to 27.9 months

5. Duration of Objective Response (OR)

   Duration of OR is defined as the time from the start of the first radiographic documentation of OR per investigator to the first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

   Time frame: Up to 27.9 months

6. Progression-free Survival (PFS)

   PFS is defined as the time from randomization to first documentation of disease progression per investigator, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

   Time frame: Up to 30 months

7. Overall Survival (OS)

   OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive.

   Time frame: Up to 30 months

8. Number of Patients Achieving Peripheral Blood Stem Cell (PBSC) Mobilization

   Defined as the number of patients who are able to adequately mobilize PBSC per investigator assessment on or after completion of study treatment, prior to subsequent anticancer therapy.

   Time frame: Up to 30 months

9. Number of Patients Receiving Autologous Stem Cell Transplant (ASCT)

   Number of patients receiving ASCT after completion of study treatment (EOT), prior to subsequent anticancer therapy.

   Time frame: Up to 30 months

Baseline characteristics

Study documents

• Study protocol · Oct 28, 2017
• Statistical analysis plan · Oct 21, 2016

Documents are hosted by the registry — open the source record to download them.