A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01786096

Collaborator

(none)

Enrollment

Locations

Arm

51.9

Duration (Months)

7.1

Patients Per Site

0.1

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 adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).

Condition or Disease	Intervention/Treatment	Phase
Burkitt Lymphoma Precursor B-cell Lymphoblastic Leukemia-Lymphoma	Drug: SGN-CD19A	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

92 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 B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

May 30, 2017

Actual Study Completion Date :

May 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-CD19A SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg	Drug: SGN-CD19A SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

Arm

Intervention/Treatment

Experimental: SGN-CD19A

SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

Drug: SGN-CD19A

SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

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 modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007) [Through 1 month post last dose]
Duration of response [Until disease progression or start of new anticancer treatment, an expected average of 3 months]
Overall survival [Until death or study closure, an expected average of 6 months]
Blood concentrations of SGN-CD19A and metabolites [Cycles 1, 2, and 4: predose, 30 minutes, and up to 2, 4, 8, 24, 72, 120, 168, and 336 hours post dose start; All other cycles: predose, 30 minutes, and 168 and 336 hours post dose start; and 1 month post last dose]
Incidence of antitherapeutic antibodies [Predose in most cycles and 1 month post last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
Eastern Cooperative Oncology Group status of 2 or lower
Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
Measurable disease

Exclusion Criteria:

Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Alabama / University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
3	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259
4	City of Hope National Medical Center	Duarte	California	United States	91010-3000
5	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
6	All Children's Hospital	Saint Petersburg	Florida	United States	33701
7	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
8	Children's Healthcare of Atlanta / Emory University	Atlanta	Georgia	United States	30322
9	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
10	Boston Children's Hospital	Boston	Massachusetts	United States	02215
11	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
12	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
13	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229