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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01786135

Collaborator

(none)

Enrollment

Locations

Arm

48.5

Duration (Months)

10.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Burkitt Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Precursor B-cell Lymphoblastic Leukemia-Lymphoma	Drug: SGN-CD19A	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Feb 16, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-CD19A SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)	Drug: SGN-CD19A SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

Arm

Intervention/Treatment

Experimental: SGN-CD19A

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

Drug: SGN-CD19A

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

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [Through 1 month post last dose]
Incidence of laboratory abnormalities [Through 1 month post last dose]

Secondary Outcome Measures

Objective response according to revised response criteria for malignant lymphoma (Cheson 2007) [Through up to approximately 6 week post last dose]
Duration of response [Until disease progression or start of new anticancer treatment, an expected average of 6 months]
Overall survival [Until death or study closure, an expected average of 1 year]
Blood concentration of SGN-CD19A and metabolites [Through up to approximately 6 weeks post last dose]
Incidence of antitherapeutic antibodies [Through up to approximately 6 weeks post last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Allogeneic stem cell transplant (SCT)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	City of Hope National Medical Center	Duarte	California	United States	91010-3000
3	Stanford Cancer Center	Stanford	California	United States	94305
4	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
6	MD Anderson Cancer Center / University of Texas	Houston	Texas	United States	77030-4095