Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT03104491|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : June 26, 2019
This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects.
The Phase II portion of this study is to see what side effects are seen with medication after transplant.
Inotuzumab ozogamicin is a combination of an antibody and chemotherapy. This means that it targets the acute lymphocytic leukemia (ALL) cell and can deliver the chemotherapy to the ALL cell. Research shows that in some patients, it has caused their disease to go back into remission.
Inotuzumab ozogamicin is considered experimental in this study.
|Condition or disease||Intervention/treatment||Phase|
|Cluster of Differentiation Antigen (CD22)-Positive Acute Lymphoblastic Leukemia||Drug: Inotuzumab Ozogamicin||Phase 1 Phase 2|
Primary Objective Phase I: To define a post hematopoietic stem cell transplantation maximum tolerated dose of inotuzumab Ozogamicin Phase II: To define the safety profile of inotuzumab Ozogamicin therapy after allogeneic transplant.
Phase II: To determine the rate of veno-occlusive disease / sinusoidal obstruction syndrome (VOD/SOS).
- To evaluate non-relapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.
- To determine the incidence of myeloid toxicity and secondary graft failure.
- To determine if inotuzumab at these doses are effective at eradicating minimal residual disease (MRD) in this cohort of patients.
Study Design This is a Phase I/II study of inotuzumab ozogamicin for the treatment of patients who underwent allogeneic transplantation for ALL and have a high risk of relapse. The Phase I portion of this study will be a 3/3 dose escalation trial with cohort expansion at the maximum tolerated dose (MTD). Subjects will receive study treatment until relapse of disease, unacceptable toxicity, 30 days after cycle 4, or death, whichever occurs first.
Phase I: Inotuzumab Ozogamicin Dosing Escalation Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach.
Phase II: Inotuzumab Ozogamicin Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach. In order to be included in the safety profile endpoint review, subjects must have received at least of 1 cycle of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inotuzumab Ozogamicin Post-Transplant for Acute Lymphocytic Leukemia|
|Actual Study Start Date :||March 21, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Inotuzumab Ozogamicin
Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach.
Drug: Inotuzumab Ozogamicin
Participants will begin at 0.6mg/m2 and will be adjusted in 0.1mg/m2 increments using a dose escalation scale depending on tolerability. Total range of dose levels is 0.1-0.6mg/m2
- Maximum tolerated dose [ Time Frame: Up to 112 days (16 weeks) ]Phase I Primary Outcome
- Post transplant relapse rate [ Time Frame: Up to 1 year after initial treatment ]Phase II Primary Outcome: number of patients with relapse after stem cell transplant
- Response Rate [ Time Frame: Up to 1 year after initial treatment ]defined as the proportion of patients with a best overall response of eradicating MRD in this cohort of patients at the time each patient discontinues treatment with Inotuzumab Ozogamicin
- Recurrence-free survival [ Time Frame: Up to 1 year after initial treatment ]Time from initial treatment to progression, death, or one year, whichever comes first
- Overall Survival [ Time Frame: Up to 1 year after initial treatment ]Time from initial treatment to death or one year, whichever comes first
- Incidence of myeloid toxicity [ Time Frame: Up to 1 year after initial treatment ]Number of patients who develop myeloid toxicity while on study
- Incidence of secondary graft failure [ Time Frame: Up to 1 year after initial treatment ]Number of patients who develop secondary graft failure while on study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104491
|Contact: Leland Metheny, MDfirstname.lastname@example.org|
|Contact: Ron Sobecks, MDemail@example.com|
|United States, Ohio|
|University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Leland Metheny, MD 216-983-4946 Leland.Metheny@uhhospitals.org|
|Principal Investigator: Leland Metheny|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Suspended|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Leland Metheny, MD||University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|