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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02855359
First Posted: August 4, 2016
Last Update Posted: November 1, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
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.

Condition Intervention Phase
Diffuse, Large B-Cell, Lymphoma Follicular Lymphoma, Grade 3b Transformed Lymphoma / DLBCL Drug: denintuzumab mafodotin Drug: rituximab Drug: cyclophosphamide Drug: doxorubicin Drug: vincristine Drug: prednisone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Part B Outcome Measure: Complete Response Rate (CR) [ Time Frame: Up to 6 months. (Six 21 day cycles plus 30 days for End of Treatment (EOT) Visit.) ]
  • Part A and Part B Outcome Measure: Incidence of adverse events [ Time Frame: Up to 6 months. (Six 21 day cycles plus 30 days for End of Treatment (EOT) Visit.) ]
  • Part A and Part B Outcome Measure: Incidence of laboratory abnormalities [ Time Frame: Up to 6 months. (Six 21 day cycles plus 30 days for End of Treatment (EOT) Visit.) ]

Secondary Outcome Measures:
  • Event-free survival (EFS) between study arms in Part B. [ Time Frame: Up to approximately 4 years. ]
  • Progression-free survival (PFS) between study arms in Part B. [ Time Frame: Up to approximately 4 years. ]
  • Overall survival (OS) between study arms in Part B. [ Time Frame: Up to approximately 4 years. ]
  • Objective response rate (ORR) at End Of Treatment (EOT) between study arms in Part B. [ Time Frame: Up to 6 months. (Six 21 day cycles plus 30 days for End of Treatment (EOT) Visit.) ]
  • Duration of objective response and of complete response (CR) between study arms in Part B. [ Time Frame: Up to approximately 4 years. ]

Enrollment: 24
Study Start Date: August 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: denintuzumab mafodotin + RCHOP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Drug: denintuzumab mafodotin
SGN-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
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Experimental: denintuzumab mafodotin + RCHP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
Drug: denintuzumab mafodotin
SGN-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
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Experimental: denintuzumab mafodotin + RCHOP or RCHP
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
Drug: denintuzumab mafodotin
SGN-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
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Active Comparator: RCHOP
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles

Detailed Description:
In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).
  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:

  • 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
  • Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
  • Eastern Cooperative Oncology Group performance status ≤2
  • Age 18 years or older
  • Adequate study baseline laboratory parameters

Exclusion Criteria:

  • Previous history of treated indolent lymphoma
  • History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
  • History of progressive multifocal leukoencephalopathy
  • Cerebral/meningeal disease related to the underlying malignancy
  • Patients with the following ocular conditions: corneal disorders, monocular vision (ie. 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): NCT02855359


  Show 35 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: NCT02855359     History of Changes
Other Study ID Numbers: SGN19A-004
First Submitted: July 28, 2016
First Posted: August 4, 2016
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Seattle Genetics, Inc.:
SGN-19A
Denintuzumab Mafodotin
Antibodies, Monoclonal
DLBCL
Antibody-Drug Conjugate
Antigens, CD19
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Immunotherapy
Lymphatic Diseases
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Monomethyl auristatin F
Neoplasms
Neoplasms by Histologic Type
Transformed Lymphoma / DLBCL
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotic, Antineoplastic
Antimitotic Agents
Antineoplastic Agents, Alkylating

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
Cyclophosphamide
Rituximab
Antineoplastic Agents, Alkylating
Liposomal doxorubicin
Doxorubicin
Prednisone
Vincristine
Antineoplastic Agents
Antibodies
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors