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. 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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