Inotuzumab Ozogamicin in Treating Participants With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
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|ClinicalTrials.gov Identifier: NCT03441061|
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Recipient B Acute Lymphoblastic Leukemia Minimal Residual Disease Philadelphia Chromosome Positive Recurrent B Acute Lymphoblastic Leukemia||Biological: Inotuzumab Ozogamicin||Phase 2|
I. To evaluate the clinical efficacy of inotuzumab ozogamicin in patients B-cell acute lymphoblastic leukemia (ALL) in complete morphologic remission with positive minimal residual disease (MRD) in terms of relapse-free survival (RFS).
I. To evaluate other efficacy endpoints such as overall survival and MRD negativity rate by flow cytometry and/or polymerase chain reaction (PCR) overall and after the first cycle, as well as safety of inotuzumab ozogamicin in this setting.
Participants receive inotuzumab ozogamicin intravenously (IV) over 1 hour on days 1, 8, and 15 of cycle 1 and days 1 and 8 of subsequent cycles. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 day and then periodically every 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Inotuzumab Ozogamicin in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease|
|Actual Study Start Date :||February 15, 2018|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2023|
Experimental: Treatment (inotuzumab ozogamicin)
Participants receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15 of cycle 1 and days 1 and 8 of subsequent cycles. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Biological: Inotuzumab Ozogamicin
- Relapse-free survival (RFS) [ Time Frame: Up to 4 years ]
- Incidence of adverse events [ Time Frame: Up to 4 years ]Will continuously monitor treatment-related toxicities using the Bayesian approach of Thall, Simon, Estey. For the purpose of toxicity monitoring, toxicities are defined as any treatment-related grade 3 or 4 non-hematologic adverse events occurring any time during the trial.
- Overall survival [ Time Frame: Up to 4 years ]
- Minimal residual disease (MRD) negativity rate [ Time Frame: Up to 4 years ]
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): NCT03441061
|Contact: Elias Jabbour, MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Elias Jabbour 713-792-4764|
|Principal Investigator: Elias Jabbour|
|Principal Investigator:||Elias Jabbour||M.D. Anderson Cancer Center|