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CompletedNCT01786135Updated Oct 19, 2017

A Safety Study of SGN-CD19A for B-Cell Lymphoma

A Phase 1 interventional study of SGN-CD19A in Burkitt Lymphoma, Lymphoma, Follicular and Lymphoma, Large B-Cell, Diffuse, sponsored by Seagen Inc.. Completed at 6 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by Seagen Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
12 Years and older
Sex
All
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Study 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)

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Conditions studied

  • 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
  • Drug Therapy
  • Monomethylauristatin F
  • Follicular Lymphoma Grade 3
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In context

Burkitt Lymphoma

392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.

This study's enrollment of 64 is above the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.

Browse Burkitt Lymphoma studies →

Lead sponsor

Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Allogeneic stem cell transplant (SCT)
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    SGN-CD19A

    SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

    Drug: SGN-CD19A

Interventions

  • DrugSGN-CD19A

    SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

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What researchers measure

Primary outcomes

  1. Incidence of adverse events

    Time frame: Through 1 month post last dose

  2. Incidence of laboratory abnormalities

    Time frame: Through 1 month post last dose

Secondary outcomes

  1. Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)

    Time frame: Through up to approximately 6 week post last dose

  2. Duration of response

    Time frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months

  3. Overall survival

    Time frame: Until death or study closure, an expected average of 1 year

  4. Blood concentration of SGN-CD19A and metabolites

    Time frame: Through up to approximately 6 weeks post last dose

  5. Incidence of antitherapeutic antibodies

    Time frame: Through up to approximately 6 weeks post last dose

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Study locations

6 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • City of Hope National Medical Center
    Duarte, California 91010-3000, United States
  • Stanford Cancer Center
    Stanford, California 94305, United States
  • H. Lee Moffitt Cancer Center & Research Institute
    Tampa, Florida 33612, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
  • MD Anderson Cancer Center / University of Texas
    Houston, Texas 77030-4095, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01786135
Lead sponsor
Seagen Inc.
Responsible party
Sponsor
First posted
Feb 7, 2013
Start date
Feb 2013
Primary completion
Aug 2015
Completion
Feb 16, 2017
Last update
Oct 19, 2017

Study contacts

Ana Kostic, MD
study director · Seagen Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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