Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Status:	Active, not recruiting
Conditions:	Blood Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	August 2011
End Date:	February 2016

An Open-label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-positive Acute Lymphocytic Leukemia

The Phase 1 portion of this study will 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. The Phase 2 portion of the study will evaluate the efficacy of
inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in
second or later salvage status.

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 enrolled in the Phase 2 portion of the
study must be due to receive salvage 2 or later therapy.

- 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).

We found this trial at

sites

University of Texas M.D. Anderson Cancer Center

1515 Holcombe Blvd
Houston, Texas 77030

713-792-2121