Burkitt LymphomaPhase 1NCT01786135
A Safety Study of SGN-CD19A for B-Cell Lymphoma
A Phase 1 study testing SGN-CD19A in people with Burkitt Lymphoma and Lymphoma, Follicular, run by Seagen Inc. at 6 sites in United States.
Trial summary
This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- SGN-CD19A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2013to 16 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
- Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
- Eastern Cooperative Oncology Group status of 0 or 1
- Measurable disease
Who cannot join
- Allogeneic stem cell transplant (SCT)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
City of Hope National Medical Center
Duarte, California, 91010-3000
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Stanford Cancer Center
Stanford, California, 94305
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)
- Conditions
- Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
- Being tested
- SGN-CD19A
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD19, B-Lineage Lymphoblastic Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, B-Cell Lymphoma, Drug Therapy, Monomethylauristatin F, Follicular Lymphoma Grade 3
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-CD19ADrug
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
| Study group | Role | What they receive |
|---|---|---|
| SGN-CD19A | Experimental | SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks) Receives: Drug: SGN-CD19A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Through 1 month post last dose
Incidence of laboratory abnormalities
Measured: Through 1 month post last dose
Secondary outcomes (5)
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
Measured: Through up to approximately 6 week post last dose
Duration of response
Measured: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Measured: Until death or study closure, an expected average of 1 year
Blood concentration of SGN-CD19A and metabolites
Measured: Through up to approximately 6 weeks post last dose
Incidence of antitherapeutic antibodies
Measured: Through up to approximately 6 weeks post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2015
- Study completion16 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burkitt 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Kostic, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786135
- Sponsor's protocol ID
- SGN19A-002
- Status last verified
- Jun 2017
- First submitted
- 5 Feb 2013
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01786135
- Acronym / sponsor ID
- SGN19A-002
- Conditions
- Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD19, B-Lineage Lymphoblastic Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, B-Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
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 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGN-CD19A | Experimental | Drug: SGN-CD19ASGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
- Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
- Eastern Cooperative Oncology Group status of 0 or 1
- Measurable disease
Key exclusion criteria (1 listed)
- Allogeneic stem cell transplant (SCT)
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 |
|---|---|---|
| SGN-CD19ASGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks) | Drug | SGN-CD19A |
Primary outcome
Incidence of adverse events
Time frame: Through 1 month post last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month post last dose
5 secondary outcomes
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
Time frame: Through up to approximately 6 week post last dose
Duration of response
Time frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Time frame: Until death or study closure, an expected average of 1 year
Blood concentration of SGN-CD19A and metabolites
Time frame: Through up to approximately 6 weeks post last dose
Incidence of antitherapeutic antibodies
Time frame: Through up to approximately 6 weeks post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
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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.
Ana Kostic, MD study director
Seagen Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGN-CD19A in people with Burkitt Lymphoma and Lymphoma, Follicular, run by Seagen Inc. at 6 sites in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (time frame: Through 1 month post last dose). The study lists 2 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 19 Oct 2017.