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

This study is currently recruiting participants.
Verified December 2017 by Seattle Genetics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02592876
First Posted: October 30, 2015
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
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.

Condition Intervention Phase
Lymphoma, B-cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular, Grade 3b Follicular Lymphoma, Grade 3b Drug: denintuzumab mafodotin Drug: rituximab Drug: ifosfamide Drug: carboplatin Drug: etoposide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Complete remission rate [ Time Frame: Up to 4 months ]

Secondary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Up to 4 months ]
  • Objective response rate [ Time Frame: Up to 4 months ]
  • Duration of response [ Time Frame: Up to approximately 5 years ]
  • Progression-free survival [ Time Frame: Up to approximately 5 years ]
  • Overall survival [ Time Frame: Up to approximately 5 years ]
  • Proportion of patients achieving peripheral blood stem cell mobilization [ Time Frame: Up to approximately 5 years ]
  • Proportion of patients receiving autologous stem cell transplant [ Time Frame: Up to approximately 5 years ]

Estimated Enrollment: 150
Study Start Date: October 2015
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 19A+RICE
Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide
Drug: denintuzumab mafodotin
Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.
Other Name: SGN-CD19A
Drug: rituximab
375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles
Drug: ifosfamide
5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles
Drug: carboplatin
AUC 5 by IV infusion, every 3 weeks for up to 3 cycles
Drug: etoposide
100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles
Active Comparator: RICE
Rituximab, ifosfamide, carboplatin, and etoposide
Drug: rituximab
375 mg/m2 by IV infusion, every 3 weeks for up to 3 cycles
Drug: ifosfamide
5000 mg/m2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles
Drug: carboplatin
AUC 5 by IV infusion, every 3 weeks for up to 3 cycles
Drug: etoposide
100 mg/m2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL; including de novo and transformed DLBCL) or Grade 3b follicular lymphoma
  • Available representative tissue from the most recent biopsy after the last therapy; if such tissue is not available, a fresh biopsy must be obtained
  • Received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy, and radiotherapy in a limited field or as part of the frontline treatment plan are permitted.
  • Achieved a response of stable disease, partial response, or complete response following the last cycle of frontline treatment. In addition, patients must have relapsed ≤6 months from the completion of frontline therapy at the time of initial dosing in this clinical trial.
  • Considered eligible for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
  • Fluorodeoxyglucose (FDG)-avid disease by positive emission tomography (PET), and measurable disease greater than 1.5 cm in diameter
  • Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2
  • Adequate kidney and hematologic function assessed from baseline laboratory data

Exclusion Criteria:

  • Previous history of indolent lymphoma treated with more than 1 multi-agent chemotherapy regimen or previous cancer therapy for recurrent DLBCL or Grade 3b follicular lymphoma
  • History of autologous or allogeneic stem cell transplant
  • History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year
  • History of progressive multifocal leukoencephalopathy (PML)
  • Cerebral/meningeal disease related to the underlying malignancy that has not been definitively treated
  • Known urinary tract obstruction
  • Patients with the following ocular conditions: corneal disorders, monocular vision (i.e., best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592876


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

  Show 30 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Juan Pinelli, PA-C, MMSc Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02592876     History of Changes
Other Study ID Numbers: SGN19A-003
First Submitted: October 29, 2015
First Posted: October 30, 2015
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Seattle Genetics, Inc.:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide phosphate
Isophosphamide mustard
Carboplatin
Rituximab
Etoposide
Ifosfamide
Antibodies
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents