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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

Primary Purpose

Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3b, Transformed Lymphoma / DLBCL

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
denintuzumab mafodotin
rituximab
cyclophosphamide
doxorubicin
vincristine
prednisone
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse, Large B-Cell, Lymphoma focused on measuring Antibodies, Monoclonal, SGN-19A, Denintuzumab Mafodotin, 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, Antineoplastic Agents, Phytogenic Antirheumatic Agents, Glucocorticoids, Drug Therapy, Follicular Lymphoma Grade 3b, immunosuppressive agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Saint Bernards Cancer Center
  • City of Hope
  • Compassionate Cancer Care Medical Group, Inc.
  • Pacific Hematology Oncology Associates
  • University of Colorado Health Memorial Hospital
  • Poudre Valley Hospital Harmony Campus
  • Central Georgia Cancer Care
  • Loyola University Medical Center
  • University of Iowa Hospitals and Clinics
  • Norton Cancer Institute
  • Montgomery Cancer Center
  • Tulane University Hospital and Clinic
  • University of Michigan Comprehensive Cancer Center
  • Virginia Piper Cancer Institute
  • Hattiesburg Clinic (Forrest General Hospital)
  • Research Medical Center
  • San Juan Oncology Associates
  • Montefiore Medical Center - Bronx
  • Mount Sinai Hospital
  • Duke University Medical Center
  • Regional Medical Oncology Center
  • Gabrail Cancer Center Research
  • University Hospitals Seidman Cancer Center
  • Thomas Jefferson University Hospital
  • University of Pittsburgh Medical Center
  • Hollings Cancer Center
  • Tennessee Oncology / Sarah Cannon Research Institute
  • Baylor Health - Baylor University Medical Center
  • Joe Arrington Cancer Research and Treatment Center
  • Scott and White Memorial Hospital - Temple
  • Kadlec Clinic Hematology and Oncology
  • Vista Oncology INC PS
  • Northwest Medical Specialties, PLLC
  • Ponce Medical School Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

denintuzumab mafodotin + RCHOP

denintuzumab mafodotin + RCHP

denintuzumab mafodotin + RCHOP or RCHP

RCHOP

Arm Description

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)

Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP

Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Outcomes

Primary Outcome Measures

Part B Outcome Measure: Complete Response Rate (CR)
Study did not progress to Part B.
Part A and Part B Outcome Measure: Incidence of Adverse Events
Part A data only; study did not progress to Part B.
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.

Secondary Outcome Measures

Event-free Survival (EFS) Between Study Arms in Part B
Study did not progress to Part B
Progression-free Survival (PFS) Between Study Arms in Part B
Study did not progress to Part B.
Overall Survival (OS) Between Study Arms in Part B
Study did not progress to Part B.
Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B
Study did not progress to Part B.
Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
Study did not progress to Part B.

Full Information

First Posted
July 28, 2016
Last Updated
February 11, 2019
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02855359
Brief Title
Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3b, Transformed Lymphoma / DLBCL
Keywords
Antibodies, Monoclonal, SGN-19A, Denintuzumab Mafodotin, 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, Antineoplastic Agents, Phytogenic Antirheumatic Agents, Glucocorticoids, Drug Therapy, Follicular Lymphoma Grade 3b, immunosuppressive agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
denintuzumab mafodotin + RCHOP
Arm Type
Experimental
Arm Description
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Arm Title
denintuzumab mafodotin + RCHP
Arm Type
Experimental
Arm Description
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
Arm Title
denintuzumab mafodotin + RCHOP or RCHP
Arm Type
Experimental
Arm Description
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
Arm Title
RCHOP
Arm Type
Active Comparator
Arm Description
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Intervention Type
Drug
Intervention Name(s)
denintuzumab mafodotin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Description
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
vincristine
Intervention Description
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Primary Outcome Measure Information:
Title
Part B Outcome Measure: Complete Response Rate (CR)
Description
Study did not progress to Part B.
Time Frame
N/A - Endpoint not assessed
Title
Part A and Part B Outcome Measure: Incidence of Adverse Events
Description
Part A data only; study did not progress to Part B.
Time Frame
54.7 weeks
Title
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Description
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.
Time Frame
Up to 183 days
Secondary Outcome Measure Information:
Title
Event-free Survival (EFS) Between Study Arms in Part B
Description
Study did not progress to Part B
Time Frame
N/A - Endpoint not assessed
Title
Progression-free Survival (PFS) Between Study Arms in Part B
Description
Study did not progress to Part B.
Time Frame
N/A - Endpoint not assessed
Title
Overall Survival (OS) Between Study Arms in Part B
Description
Study did not progress to Part B.
Time Frame
N/A - Endpoint not assessed
Title
Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B
Description
Study did not progress to Part B.
Time Frame
N/A - Endpoint not assessed
Title
Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
Description
Study did not progress to Part B.
Time Frame
N/A - Endpoint not assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Pinelli, PA-C, MMSc.
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Saint Bernards Cancer Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Compassionate Cancer Care Medical Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Health Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Poudre Valley Hospital Harmony Campus
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Central Georgia Cancer Care
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Montgomery Cancer Center
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hattiesburg Clinic (Forrest General Hospital)
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Montefiore Medical Center - Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Regional Medical Oncology Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University Hospitals Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Oncology / Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Health - Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Scott and White Memorial Hospital - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Vista Oncology INC PS
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Ponce Medical School Foundation
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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