Know Cancer

or
forgot password

An Open-Label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory CD22-Positive Acute Lymphocytic Leukemia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Lymphocytic Leukemia

Thank you

Trial Information

An Open-Label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory CD22-Positive Acute Lymphocytic Leukemia


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1: Dose-Finding First cycle dose limiting toxicities (DLTs).

Outcome Time Frame:

duration of first cycle, approximately 1-56 days from first dose

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1931010

NCT ID:

NCT01363297

Start Date:

August 2011

Completion Date:

December 2015

Related Keywords:

  • Acute Lymphocytic Leukemia
  • Relapsed/Refractory Acute Lymphocytic Leukemia (ALL)
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteNorth Adams, Massachusetts  01247