Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01363297
First received: May 11, 2011
Last updated: May 31, 2013
Last verified: May 2013
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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 CD22 saturation kinetics, 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: | December 2015 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363297
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| Stanford, California, United States, 94305 | |
| United States, Illinois | |
| Pfizer Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Pfizer Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Pfizer Investigational Site | Recruiting |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Ohio | |
| Pfizer Investigational Site | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| United States, Washington | |
| Pfizer Investigational Site | Recruiting |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Pfizer
UCB, Inc.
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: | May 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Relapsed/Refractory Acute Lymphocytic Leukemia (ALL) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013