Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01363297
First received: May 11, 2011
Last updated: September 8, 2014
Last verified: September 2014
  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.


Condition Intervention Phase
Acute Lymphocytic Leukemia
Drug: Inotuzumab Ozogamicin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory CD22-Positive Acute Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Part 1: Dose-Finding First cycle dose limiting toxicities (DLTs). [ Time Frame: duration of first cycle, approximately 1-56 days from first dose ] [ Designated as safety issue: Yes ]
  • Part 1: Dose-Finding Preliminary efficacy, including non-progressive disease (PD) after the first cycle. [ Time Frame: duration of first cycle, approximately 28-56 days from first dose ] [ Designated as safety issue: No ]
  • Part 2: Expansion Cohort Hematologic remission [complete response (CR) and complete response with incomplete count recovery (CRi)] [ Time Frame: duration of treatment period, approximately 2-6 months from first dose ] [ Designated as safety issue: No ]
  • Part 3: Phase 2 Hematologic remission [complete response (CR) and complete response with incomplete count recovery (CRi)] [ Time Frame: duration of treatment period, approximately 2-6 months from first dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematologic response, including complete response (CR), complete response with incomplete count recovery (CRi) and partial response (PR) [ Time Frame: duration of treatment period, approximately 2-6 months from first dose ] [ Designated as safety issue: No ]
  • Minimal residual disease levels and cytogenetics in subjects achieving hematologic remission (CR + CRi) [ Time Frame: duration of treatment period, approximately 2-6 months from first dose ] [ Designated as safety issue: No ]
  • Number of subjects who undergo stem-cell transplant following treatment with inotuzumab ozogamicin [ Time Frame: duration of long-term follow-up period, up to 2 years from first dose ] [ Designated as safety issue: No ]
  • Duration of response (DoR) [ Time Frame: duration of treatment and long-term follow-up periods, up to 2 years from first dose ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: duration of treatment and long-term follow-up periods, up to 2 years from first dose ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: duration of treatment and long-term follow-up periods, up to 2 years from first dose ] [ Designated as safety issue: No ]
  • Population pharmacokinetic parameters of inotuzumab ozogamicin, including clearance and volume of distribution for the typical subject as well as the individual [ Time Frame: up to 4 cycles, approximately 4 months from the first dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameters of inotuzumab ozogamicin, including rate of clearance of CD22-positive B-cells from peripheral blood, and PK/PD relationship [ Time Frame: up to 4 cycles, approximately 4 months from the first dose ] [ Designated as safety issue: No ]
  • Pharmacogenomic parameters including expression of genes related to DNA repair and susceptibility to apoptosis triggered by double-stranded DNA breaks [ Time Frame: duration of first half of cycle 1, approximately 2 weeks from first dose ] [ Designated as safety issue: No ]
  • Duration of remission (DoR1) [ Time Frame: duration of treatment and long-term follow-up periods, up to 2 years from first dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: August 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inotuzumab Ozogamicin 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.

Other Name: CMC-544

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363297

Locations
United States, California
Pfizer Investigational Site
Duarte, California, United States, 91010
Pfizer Investigational Site
Stanford, California, United States, 94305
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 2114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Boston, Massachusetts, United States, 02284-9168
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Pfizer
UCB Pharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01363297     History of Changes
Other Study ID Numbers: B1931010, 3129K6-1106
Study First Received: May 11, 2011
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relapsed/Refractory Acute Lymphocytic Leukemia (ALL)

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014