Phase 1 Program

SCCA Clinical Studies: Phase 1 Program

Inotuzumab Ozogamicin for Acute Lymphocytic Leukemia
An Open-Label, Phase 1 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory CD22-Positive Acute Lymphocytic Leukemia
Status Conditions Phase Study ID
Closed Acute Lymphocytic Leukemia Phase I NCT01363297

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.

Andrei Shustov, MD
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)

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).
Last Updated
May 12, 2014
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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