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A Safety Study of SGN-CD19A for Leukemia and Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01786096
First received: February 5, 2013
Last updated: June 29, 2017
Last verified: June 2017
February 5, 2013
June 29, 2017
February 2013
May 30, 2017   (Final data collection date for primary outcome measure)
  • Incidence of adverse events [ Time Frame: Through 1 month post last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month post last dose ]
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 ]
  • Duration of response [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 3 months ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 6 months ]
  • 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 ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Predose in most cycles and 1 month post last dose ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Completed
92
May 30, 2017
May 30, 2017   (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
Sexes Eligible for Study: All
1 Year and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01786096
SGN19A-001
No
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Eric Feldman, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
June 2017

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