Diffuse, Large B-Cell, LymphomaPhase 2NCT02855359
Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
A Phase 2 study testing denintuzumab mafodotin, rituximab and cyclophosphamide in people with Diffuse, Large B-Cell, Lymphoma and Follicular Lymphoma, Grade 3b, run by Seagen Inc. at 35 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3b, Transformed Lymphoma / DLBCL
- What is being tested?
- denintuzumab mafodotin, rituximab and cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Aug 2016to 15 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States34 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Gabrail Cancer Center Research
Canton, Ohio, 44718
Hollings Cancer Center
Charleston, South Carolina, 29425
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
University of Colorado Health Memorial Hospital
Colorado Springs, Colorado, 80909
Baylor Health - Baylor University Medical Center
Dallas, Texas, 75246
City of Hope
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
San Juan Oncology Associates
Farmington, New Mexico, 87401
Poudre Valley Hospital Harmony Campus
Fort Collins, Colorado, 80528
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708
Hattiesburg Clinic (Forrest General Hospital)
Hattiesburg, Mississippi, 39401
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Saint Bernards Cancer Center
Jonesboro, Arkansas, 72401
Research Medical Center
Kansas City, Missouri, 64132
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Norton Cancer Institute
Louisville, Kentucky, 40207
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
Central Georgia Cancer Care
Macon, Georgia, 31201
Loyola University Medical Center
Maywood, Illinois, 60153
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353
Tennessee Oncology / Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70122
Mount Sinai Hospital
New York, New York, 10029
Vista Oncology INC PS
Olympia, Washington, 98502
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Pacific Hematology Oncology Associates
San Francisco, California, 94115
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Scott and White Memorial Hospital - Temple
Temple, Texas, 76508
Montefiore Medical Center - Bronx
The Bronx, New York, 10467
Regional Medical Oncology Center
Wilson, North Carolina, 27893
About this study
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
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.
Read the 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).
- Conditions
- Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3b, Transformed Lymphoma / DLBCL
- Being tested
- denintuzumab mafodotin, rituximab, cyclophosphamide, doxorubicin, vincristine
- 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
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Hematologic Diseases, Immune System Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denintuzumab mafodotinDrug
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
rituximabDrug
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamideDrug
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicinDrug
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristineDrug
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisoneDrug
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| denintuzumab mafodotin + RCHOP | Experimental | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) Receives: Drug: denintuzumab mafodotin; Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone |
| denintuzumab mafodotin + RCHP | Experimental | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) Receives: Drug: denintuzumab mafodotin; Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: prednisone |
| denintuzumab mafodotin + RCHOP or RCHP | Experimental | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP Receives: Drug: denintuzumab mafodotin; Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone |
| RCHOP | Active comparator | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) Receives: Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B Outcome Measure: Complete Response Rate (CR)
Study did not progress to Part B.
Measured: N/A - Endpoint not assessed
Part A and Part B Outcome Measure: Incidence of Adverse Events
Part A data only; study did not progress to Part B.
Measured: 54.7 weeks
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.
Measured: Up to 183 days
Secondary outcomes (5)
Event-free Survival (EFS) Between Study Arms in Part B
Study did not progress to Part B
Measured: N/A - Endpoint not assessed
Progression-free Survival (PFS) Between Study Arms in Part B
Study did not progress to Part B.
Measured: N/A - Endpoint not assessed
Overall Survival (OS) Between Study Arms in Part B
Study did not progress to Part B.
Measured: N/A - Endpoint not assessed
Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B
Study did not progress to Part B.
Measured: N/A - Endpoint not assessed
Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
Study did not progress to Part B.
Measured: N/A - Endpoint not assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2018
- Study completion15 May 2018
Why it stopped: Sponsor decision based on portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse, Large B-Cell, LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Pinelli, PA-C, MMSc., Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855359
- Sponsor's protocol ID
- SGN19A-004
- Status last verified
- Feb 2019
- First submitted
- 28 Jul 2016
- Last updated
- 11 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02855359
- Acronym / sponsor ID
- SGN19A-004
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| denintuzumab mafodotin + RCHOP | Experimental | Drug: denintuzumab mafodotin, Drug: rituximab, Drug: cyclophosphamide, Drug: doxorubicin, Drug: vincristine, Drug: prednisonePart A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) |
| denintuzumab mafodotin + RCHP | Experimental | Drug: denintuzumab mafodotin, Drug: rituximab, Drug: cyclophosphamide, Drug: doxorubicin, Drug: prednisonePart A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) |
| denintuzumab mafodotin + RCHOP or RCHP | Experimental | Drug: denintuzumab mafodotin, Drug: rituximab, Drug: cyclophosphamide, Drug: doxorubicin, Drug: vincristine, Drug: prednisonePart B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP |
| RCHOP | Active comparator | Drug: rituximab, Drug: cyclophosphamide, Drug: doxorubicin, Drug: vincristine, Drug: prednisonePart B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| denintuzumab mafodotinSGN-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 | denintuzumab mafodotin + RCHOP, denintuzumab mafodotin + RCHOP or RCHP, denintuzumab mafodotin + RCHP |
| rituximab375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | Drug | RCHOP, denintuzumab mafodotin + RCHOP, denintuzumab mafodotin + RCHOP or RCHP, denintuzumab mafodotin + RCHP |
| cyclophosphamide750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | Drug | RCHOP, denintuzumab mafodotin + RCHOP, denintuzumab mafodotin + RCHOP or RCHP, denintuzumab mafodotin + RCHP |
| doxorubicin50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | Drug | RCHOP, denintuzumab mafodotin + RCHOP, denintuzumab mafodotin + RCHOP or RCHP, denintuzumab mafodotin + RCHP |
| vincristine1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) | Drug | RCHOP, denintuzumab mafodotin + RCHOP, denintuzumab mafodotin + RCHOP or RCHP |
| prednisone100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Drug | RCHOP, denintuzumab mafodotin + RCHOP, denintuzumab mafodotin + RCHOP or RCHP, denintuzumab mafodotin + RCHP |
Primary outcome
Part B Outcome Measure: Complete Response Rate (CR)
Time frame: N/A - Endpoint not assessed
Study did not progress to Part B.
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.
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.
5 secondary outcomes
Event-free Survival (EFS) Between Study Arms in Part B
Time frame: N/A - Endpoint not assessed
Progression-free Survival (PFS) Between Study Arms in Part B
Time frame: N/A - Endpoint not assessed
Overall Survival (OS) Between Study Arms in Part B
Time frame: 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
Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
Time frame: N/A - Endpoint not assessed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Pinelli, PA-C, MMSc. study director
Seagen Inc.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing denintuzumab mafodotin, rituximab and cyclophosphamide in people with Diffuse, Large B-Cell, Lymphoma and Follicular Lymphoma, Grade 3b, run by Seagen Inc. at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part B Outcome Measure: Complete Response Rate (CR) (time frame: N/A - Endpoint not assessed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.