Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
Status: Recruiting
Phase:
Diagnosis: Leukemia/MDS
NCT ID: NCT01363297
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-171
The purpose of this study is to assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule.
Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center
Overall PI:
Daniel DeAngelo, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Karen Ballen, MD,
Massachusetts General Hospital
Jacalyn Rosenblatt, MD,
Beth Israel Deaconess Medical Center
Contacts:
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
Inclusion Criteria:
- Subjects with CD22-positive ALL with either refractory disease (i.e. disease
progression or no response while receiving their most recent prior anti-cancer
therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer
therapy with subsequent relapse).
- Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard
treatment with at least one tyrosine kinase inhibitor.
- Adequate renal and hepatic function, and negative pregnancy test for women of
childbearing potential.
Exclusion Criteria:
- Subjects with isolated extramedullary relapse or active central nervous system (CNS)
leukemia.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22
immunotherapy within 4 months, or active graft versus host disease (GvHD) at study
entry.
- Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction
syndrome (SOS).