Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Acute Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01363297
• Other study ID #: B1931010
• Secondary ID: 3129K6-1106
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: May 11, 2011
• Last updated: August 20, 2015
• Start date: August 2011
• Est. completion date: February 2016

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: February 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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).

Study Design

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

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Inotuzumab Ozogamicin
Part 1: Administered intravenously as 2 - 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total dose per cycle 0.8 mg/m^2 to 2.0 mg/m^2. Part 2 Expansion and Part 3 Phase 2: Administered intravenously as 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total initial dose per cycle 1.8 mg/m^2.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital (MGH)	Boston	Massachusetts
United States	Brigham and Women's Hospital (BWH)	BostonMA	Massachusetts
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Karmanos Cancer Institute at Farmington Hills	Farmington Hills	Michigan
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Stanford Unversity Cancer Clinical Trials Office	Palo Alto	California
United States	Stanford Unversity Hospital and Clinics, CTRU	Palo Alto	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Stanford Cancer Institute	Stanford	California
United States	Stanford University Hospital and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Dose-Finding First cycle dose limiting toxicities (DLTs).		duration of first cycle, approximately 1-56 days from first dose	Yes
Primary	Part 1: Dose-Finding Preliminary efficacy, including non-progressive disease (PD) after the first cycle.		duration of first cycle, approximately 28-56 days from first dose	No
Primary	Part 2: Expansion Cohort Hematologic remission [complete response (CR) and complete response with incomplete count recovery (CRi)]		duration of treatment period, approximately 2-6 months from first dose	No
Primary	Part 3: Phase 2 Hematologic remission [complete response (CR) and complete response with incomplete count recovery (CRi)]		duration of treatment period, approximately 2-6 months from first dose	No
Secondary	Hematologic response, including complete response (CR), complete response with incomplete count recovery (CRi) and partial response (PR)		duration of treatment period, approximately 2-6 months from first dose	No
Secondary	Minimal residual disease levels and cytogenetics in subjects achieving hematologic remission (CR + CRi)		duration of treatment period, approximately 2-6 months from first dose	No
Secondary	Number of subjects who undergo stem-cell transplant following treatment with inotuzumab ozogamicin		duration of long-term follow-up period, up to 2 years from first dose	No
Secondary	Duration of response (DoR)		duration of treatment and long-term follow-up periods, up to 2 years from first dose	No
Secondary	Progression-free survival (PFS)		duration of treatment and long-term follow-up periods, up to 2 years from first dose	No
Secondary	Overall survival (OS)		duration of treatment and long-term follow-up periods, up to 2 years from first dose	No
Secondary	Population pharmacokinetic parameters of inotuzumab ozogamicin, including clearance and volume of distribution for the typical subject as well as the individual		up to 4 cycles, approximately 4 months from the first dose	No
Secondary	Pharmacodynamic parameters of inotuzumab ozogamicin, including rate of clearance of CD22-positive B-cells from peripheral blood, and PK/PD relationship		up to 4 cycles, approximately 4 months from the first dose	No
Secondary	Pharmacogenomic parameters including expression of genes related to DNA repair and susceptibility to apoptosis triggered by double-stranded DNA breaks		duration of first half of cycle 1, approximately 2 weeks from first dose	No
Secondary	Duration of remission (DoR1)		duration of treatment and long-term follow-up periods, up to 2 years from first dose	No

External Links

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