Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Safety Study of SGN-CD19A for Leukemia and Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01786096
First received: February 5, 2013
Last updated: November 4, 2014
Last verified: November 2014

February 5, 2013
November 4, 2014
February 2013
December 2015   (final data collection date for primary outcome measure)
  • Incidence of adverse events [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01786096 on ClinicalTrials.gov Archive Site
  • Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007) [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 3 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 6 months ] [ Designated as safety issue: No ]
  • Blood concentrations of SGN-CD19A and metabolites [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Predose in most cycles and 1 month post last dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Safety Study of SGN-CD19A for Leukemia and Lymphoma
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Burkitt Lymphoma
  • Precursor B-cell Lymphoblastic Leukemia-Lymphoma
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
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
Intervention: Drug: SGN-CD19A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
175
June 2016
December 2015   (final data collection date for primary outcome measure)

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

Both
1 Year and older
No
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com
United States
 
NCT01786096
SGN19A-001
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Tina Albertson, MD, PhD Seattle Genetics, Inc.
Seattle Genetics, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP