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

February 11, 2019 updated by: Seagen Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Saint Bernards Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • San Francisco, California, United States, 94115
        • Pacific Hematology Oncology Associates
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • University of Colorado Health Memorial Hospital
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Hospital Harmony Campus
    • Georgia
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
      • Mount Sterling, Kentucky, United States, 40353
        • Montgomery Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70122
        • Tulane University Hospital and Clinic
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University Of Michigan Comprehensive Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic (Forrest General Hospital)
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Bronx
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Wilson, North Carolina, United States, 27893
        • Regional Medical Oncology Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Seidman Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology / Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Health - Baylor University Medical Center
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital - Temple
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Olympia, Washington, United States, 98502
        • Vista Oncology Inc Ps
      • Tacoma, Washington, United States, 98405
        • NorthWest Medical Specialties, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part B Outcome Measure: Complete Response Rate (CR)
Time Frame: N/A - Endpoint not assessed
Study did not progress to Part B.
N/A - Endpoint not assessed
Part A and Part B Outcome Measure: Incidence of Adverse Events
Time Frame: 54.7 weeks
Part A data only; study did not progress to Part B.
54.7 weeks
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Time Frame: Up to 183 days
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.
Up to 183 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event-free Survival (EFS) Between Study Arms in Part B
Time Frame: N/A - Endpoint not assessed
Study did not progress to Part B
N/A - Endpoint not assessed
Progression-free Survival (PFS) Between Study Arms in Part B
Time Frame: N/A - Endpoint not assessed
Study did not progress to Part B.
N/A - Endpoint not assessed
Overall Survival (OS) Between Study Arms in Part B
Time Frame: N/A - Endpoint not assessed
Study did not progress to Part B.
N/A - Endpoint not assessed
Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B
Time Frame: N/A - Endpoint not assessed
Study did not progress to Part B.
N/A - Endpoint not assessed
Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
Time Frame: N/A - Endpoint not assessed
Study did not progress to Part B.
N/A - Endpoint not assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seagen Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Juan Pinelli, PA-C, MMSc., Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGN19A-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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