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inotuzumab ozogamicin-dose level 2 for Acute Lymphoblastic Leukemia
Study Summary
This trial will study a lower dose of inotuzumab ozogamicin to see if it is safe and effective for patients with relapsed or refractory ALL.
- Acute Lymphoblastic Leukemia
- Leukemia
- B-Cell Lymphoblastic Leukemia/Lymphoma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 4 trial • 102 Patients • NCT03677596Trial Design
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Frequently Asked Questions
What is the maximum number of participants that this research project can accommodate?
"As of November 21st, 2022 this clinical trial is not presently seeking any new candidates. The study was first posted on July 1st 2019 and has since been inactive. However, there are 1496 trials related to leukemia that are still recruiting patients as well as 17 studies involving inotuzumab ozogamicin-dose level 2 currently enrolling participants."
Has the FDA officially sanctioned inotuzumab ozogamicin at dosage level 2?
"Via a scale rating from 1 to 3, our Power team assigned inotuzumab ozogamicin-dose level 2 with a score of 3 due its approval status as part of this Phase 4 trial."
What conclusions have been derived from past experiments of inotuzumab ozogamicin-dose level 2?
"Inotuzumab ozogamicin at dose level 2 was initially tested in 2011 by the M D Anderson Cancer Center. Since then, 15 studies have come to a conclusion and 17 trials are still ongoing with several of them being conducted from Winston-Salem, North carolina."
At what number of sites is this research initiative being conducted?
"Eleven clinical sites are carrying out this research, which include Winston-Salem, Omaha and Valhalla. To make the process easier for participants, it is recommended that they select a site close to their residence in order to reduce travel complications."
What are the primary aims of this medical experiment?
"This trial's primary goal, which must be assessed over the course of two years from randomization, is to determine the Percentage of Participants With Hematologic Remission (CR/CRi). Secondary objectives include achieving Minimal Residual Disease (MRD) negativity through multiparametric flow cytometry scans of bone marrow aspirates and peripheral blood samples. Additionally, pharmacokinetics such as Clearance will also be considered alongside Post HSCT mortality."
Are septuagenarians within the parameters of this investigation?
"This clinical trial requires participants to be aged between 18 and 75. However, there are 471 trials available for minors and 1,200 studies open to those above the age of 65 years old."
Am I eligible to partake in the research initiative?
"The medical study is currently recruiting 102 leukemia patients whose ages range from 18 to 75. Prerequisites for participation include: having received or being eligible for Salvage 2 treatment, history of hepatic issues such as hepatitis and drug-induced liver damage, presence of lymphoblastic lymphoma with bone marrow involvement at a level ≥5% blasts by morphologic assessment, prior HSCT (hematopoietic stem cell transplantation), age 55+ years old, Ph+ ALL patients that have failed 1st/2nd generation tyrosine kinase inhibitor treatments plus standard multi agent induction chemotherapy in the case of late relapse during salvage 1 period"
Are more participants being enrolled in this clinical research project?
"Unfortunately, this trial is not presently enrolling volunteers. Originally posted on July 1st 2019 and last updated on November 21st 2022, it has been put on hiatus for the time being. However, there are still 1496 trials searching for patients with leukemia and 17 studies looking to recruit individuals in dose level 2 of inotuzumab ozogamicin."
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