A Safety Study of SGN-CD33A in AML Patients

Status: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS
NCT ID: NCT01902329 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

This study will examine the safety profile of SGN-CD33A administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.

 

Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Daniel DeAngelo, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Amir Fathi, M.D., Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Acute myeloid leukemia, positive for CD33 - Eastern Cooperative Onocology Group status of 0 or 1 - Adequate baseline renal and hepatic function - Central venous access - Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation - Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients Exclusion Criteria: - Inadequate lung function - Prior stem cell transplant - High-dose chemotherapy within 4 weeks of study drug - Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
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