Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Pfizer

Status and phase: Completed; Phase 2

Conditions: Acute Lymphocytic Leukemia

Treatments: Drug: Inotuzumab Ozogamicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363297

3129K6-1106 (Other Identifier)

B1931010

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

72 participants in 1 patient group

Inotuzumab Ozogamicin

Experimental group

Treatment:

Drug: Inotuzumab Ozogamicin