Lymphoma, B-cellPhase 2NCT01925612
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 2 study testing brentuximab vedotin, rituximab and vincristine in people with Lymphoma, B-cell and Lymphoma, Large B-cell, Diffuse, run by Seagen Inc. at 51 sites in 5 countries.
Trial summary
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse
- What is being tested?
- brentuximab vedotin, rituximab and vincristine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 51 sitesin 5 countries
- Study dates
- Aug 2013to 1 May 2017
- 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 systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
- International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
- Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL
Who cannot join
- Previous history of treated indolent lymphoma
- History of another primary malignancy that has not been in remission for 3 years
Trial locations and contacts
51 sites in 5 countries.
51 sites in 5 countries
United States36 sites
New York Oncology Hematology, P.C.
Albany, New York, 12206
Augusta University
Augusta, Georgia, 30912
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
Texas Oncology - Austin Midtown
Austin, Texas, 78705
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Johns Hopkins Medical Center
Baltimore, Maryland, 21231
Billings Clinic Cancer Research
Billings, Montana, 59101
Mid Ohio Oncology/Hematology Inc
Columbus, Ohio, 43219
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010-3000
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
US Oncology Investigational Products Center (IPC)
Fort Worth, Texas, 76177
Saint Francis Hospital / Bon Secours
Greenville, South Carolina, 29601
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Norton Cancer Institute
Louisville, Kentucky, 40202
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, 60153
Summit Medical Group
Morristown, New Jersey, 07962
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles, Illinois, 60714
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
University of Utah
Salt Lake City, Utah, 84112
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78229
Sansum Clinic
Santa Barbara, California, 93105
Benaroya Research Institute/Virginia Mason Medical Center
Seattle, Washington, 98101
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305
US Oncology Central Regulatory
The Woodlands, Texas, 77380
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, 97062
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85710
Texas Oncology - Tyler
Tyler, Texas, 75702
Czechia4 sites
Fakultni nemocnice Brno
Brno, 625 00
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Králové, 500 05
Fakultni Nemocnice Kralovske Vinohrady
Prague, 100 34
Fakultni nemocnice v Motole
Prague, 150 06
Italy4 sites
Centro di Riferimento Oncologico di Aviano
Aviano, 33081
Instituto di Ematologia ed Oncologia Medica
Bologna, 40138
Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara
Pisa, 56126
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Spain4 sites
Hospital de la Santa Creu i Sant Paul
Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Institut Català D'oncologia
L'Hospitalet de Llobregat, 08907
Complejo Hospitalano de Navarra Servicio Hematologia
Pamplona, 31130
Poland3 sites
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, 80-219
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
Olsztyn, 10-228
About this study
Official title: A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.
The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.
The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.
Read the detailed description
In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects).
The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.
- Conditions
- Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse
- Being tested
- brentuximab vedotin, rituximab, vincristine, cyclophosphamide, prednisone
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse, Monomethyl auristatin E
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
Also called Adcetris, SGN-35
1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
brentuximab vedotinDrug
Also called Adcetris, SGN-35
1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximabDrug
375 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)
cyclophosphamideDrug
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisoneDrug
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicinDrug
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Experimental | Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.2 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP. Receives: Drug: brentuximab vedotin; Drug: rituximab; Drug: vincristine; Drug: cyclophosphamide; Drug: prednisone; Drug: doxorubicin |
| Part 1: BV(1.8 mg/kg) + RCHOP | Experimental | Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.8 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP. Receives: Drug: brentuximab vedotin; Drug: rituximab; Drug: vincristine; Drug: cyclophosphamide; Drug: prednisone; Drug: doxorubicin |
| Part 2: BV(1.8 mg/kg) + RCHP | Experimental | Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
Part 2 of the study is a phase 2, non-randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). Patients in this treatment arm were enrolled into a dosing cohort with 1.8 mg/kg brentuximab vedotin administered in combination with RCHP. Receives: Drug: brentuximab vedotin; Drug: rituximab; Drug: cyclophosphamide; Drug: prednisone; Drug: doxorubicin |
| Part 3: RCHOP | Active comparator | Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. Receives: Drug: rituximab; Drug: vincristine; Drug: cyclophosphamide; Drug: prednisone; Drug: doxorubicin |
| Part 3: BV(1.8 mg/kg) + RCHP | Experimental | Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. Randomization in this part of the study is for the purpose of evaluating the safety of 1.8 mg/kg brentuximab vedotin in combination with RCHP versus standard RCHOP chemotherapy.
Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive 1.8 mg/kg brentuximab vedotin administered in combination with RCHP. Receives: Drug: brentuximab vedotin; Drug: rituximab; Drug: cyclophosphamide; Drug: prednisone; Drug: doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Measured: Up to 6 months
Incidence of Adverse Events
Number (count) of participants that experienced at least 1 adverse event.
Measured: Up to 6 months
Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Measured: Up to 6 months
Secondary outcomes (3)
Objective Response Rate
Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
Measured: Up to 6 months
Progression-free Survival
Median progression-free survival (in months) and observed minimum-maximum range.
Measured: Up to approximately 4 years
Overall Survival
Median overall survival (in months) and observed minimum-maximum range.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startAug 2013
- Primary completion1 May 2017
- Study completion1 May 2017
Why it stopped: Sponsor decision based on portfolio prioritization and changing treatment landscape in frontline DLBCL
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 Lymphoma, B-cellStudies 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Ruffner, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925612
- Sponsor's protocol ID
- SGN35-017
- Status last verified
- May 2018
- First submitted
- 15 Aug 2013
- Last updated
- 21 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT01925612
- Acronym / sponsor ID
- SGN35-017
- Conditions
- Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse, Monomethyl auristatin E
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization and changing treatment landscape in frontline DLBCL
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 21 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.
The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.
The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.
Detailed description
In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects).
The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Experimental | Drug: brentuximab vedotin, Drug: rituximab, Drug: vincristine, Drug: cyclophosphamide, Drug: prednisone, Drug: doxorubicinBrentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.2 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP. |
| Part 1: BV(1.8 mg/kg) + RCHOP | Experimental | Drug: brentuximab vedotin, Drug: rituximab, Drug: vincristine, Drug: cyclophosphamide, Drug: prednisone, Drug: doxorubicinBrentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.8 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP. |
| Part 2: BV(1.8 mg/kg) + RCHP | Experimental | Drug: brentuximab vedotin, Drug: rituximab, Drug: cyclophosphamide, Drug: prednisone, Drug: doxorubicinBrentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone Part 2 of the study is a phase 2, non-randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). Patients in this treatment arm were enrolled into a dosing cohort with 1.8 mg/kg brentuximab vedotin administered in combination with RCHP. |
| Part 3: RCHOP | Active comparator | Drug: rituximab, Drug: vincristine, Drug: cyclophosphamide, Drug: prednisone, Drug: doxorubicinRituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. |
| Part 3: BV(1.8 mg/kg) + RCHP | Experimental | Drug: brentuximab vedotin, Drug: rituximab, Drug: cyclophosphamide, Drug: prednisone, Drug: doxorubicinBrentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. Randomization in this part of the study is for the purpose of evaluating the safety of 1.8 mg/kg brentuximab vedotin in combination with RCHP versus standard RCHOP chemotherapy. Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive 1.8 mg/kg brentuximab vedotin administered in combination with RCHP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
- International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
- Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Key exclusion criteria (2 listed)
- Previous history of treated indolent lymphoma
- History of another primary malignancy that has not been in remission for 3 years
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 |
|---|---|---|
| brentuximab vedotinAlso: Adcetris, SGN-351.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles | Drug | Part 1: BV(1.2 mg/kg) + RCHOP |
| brentuximab vedotinAlso: Adcetris, SGN-351.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles | Drug | Part 1: BV(1.8 mg/kg) + RCHOP, Part 2: BV(1.8 mg/kg) + RCHP, Part 3: BV(1.8 mg/kg) + RCHP |
| rituximab375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | Drug | Part 1: BV(1.2 mg/kg) + RCHOP, Part 1: BV(1.8 mg/kg) + RCHOP, Part 2: BV(1.8 mg/kg) + RCHP, Part 3: BV(1.8 mg/kg) + RCHP, Part 3: RCHOP |
| vincristine1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) | Drug | Part 1: BV(1.2 mg/kg) + RCHOP, Part 1: BV(1.8 mg/kg) + RCHOP, Part 3: RCHOP |
| cyclophosphamide750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | Drug | Part 1: BV(1.2 mg/kg) + RCHOP, Part 1: BV(1.8 mg/kg) + RCHOP, Part 2: BV(1.8 mg/kg) + RCHP, Part 3: BV(1.8 mg/kg) + RCHP, Part 3: RCHOP |
| prednisone100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | Drug | Part 1: BV(1.2 mg/kg) + RCHOP, Part 1: BV(1.8 mg/kg) + RCHOP, Part 2: BV(1.8 mg/kg) + RCHP, Part 3: BV(1.8 mg/kg) + RCHP, Part 3: RCHOP |
| doxorubicin50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | Drug | Part 1: BV(1.2 mg/kg) + RCHOP, Part 1: BV(1.8 mg/kg) + RCHOP, Part 2: BV(1.8 mg/kg) + RCHP, Part 3: BV(1.8 mg/kg) + RCHP, Part 3: RCHOP |
Primary outcome
Complete Remission Rate
Time frame: Up to 6 months
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Incidence of Adverse Events
Time frame: Up to 6 months
Number (count) of participants that experienced at least 1 adverse event.
Incidence of Laboratory Abnormalities
Time frame: Up to 6 months
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
3 secondary outcomes
Objective Response Rate
Time frame: Up to 6 months
Progression-free Survival
Time frame: Up to approximately 4 years
Overall Survival
Time frame: Up to approximately 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katherine Ruffner study director
Seagen Inc.
51 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brentuximab vedotin, rituximab and vincristine in people with Lymphoma, B-cell and Lymphoma, Large B-cell, Diffuse, run by Seagen Inc. at 51 sites in 5 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 6 inclusion and 2 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Czechia, Italy, Spain, Poland. 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 21 Jun 2018). 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?
Complete Remission Rate (time frame: Up to 6 months). 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 21 Jun 2018.