Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Not Recruiting

Trial ID: NCT01363297

Purpose

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.

Official Title

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

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Eligibility


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).

Intervention(s):

drug: Inotuzumab Ozogamicin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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