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Experimental Drug for Leukemia Post-Stem Cell Transplant
Study Summary
This trial is testing two different doses of an experimental drug to see if it is safe and effective in treating patients with leukemia who have received a stem cell transplant from a related donor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 1 & 2 trial • 59 Patients • NCT01465347Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- My organs are healthy enough for a transplant according to hospital rules.I am preparing for a stem cell transplant for my leukemia or MDS.I am 18 years or older.My doctor recommends a specific type of stem cell transplant for me.I have the HA-1 positive genotype.I have the HLA-A*0201 type for treatment or any HLA type for control.I am HLAA*02:07 positive and meet the criteria for TSC-101.I can take care of myself and perform daily activities.My doctor may delay my treatment if I have organ problems.I do not have any significant infections or uncontrolled viruses.I have had a stem cell transplant from a donor.I have a family member who matches me closely enough to be a stem cell donor.I do not have any active heart conditions.I have the HA-2 positive genotype.I need a special treatment before a transplant due to specific antibodies.
- Group 1: TSC-100 Treatment Arm
- Group 2: TSC 101 Treatment Arm
- Group 3: Standard of Care or Control arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many venues has this clinical trial been enacted in?
"5 trial sites are participating in this clinical study, including the Karmanos Cancer Institute located in Detroit, City of Hope based in Duarte and Hackensack University Medical Center from Hackensack. Additionally, there are a couple other medical centres included as well."
What aims is this scientific experiment looking to accomplish?
"The primary endpoint of this two-year investigation is to determine the occurrence rate of adverse reactions caused by a high dosage. Secondary objectives include determining disease-free survival in patients compared with that of the control group at 18 months, contrasting relapse rates between participants and those within the comparative arm at 12 months, as well as examining disease-free survival among patients and controls after 24 months have elapsed. Participants alive without evidence of their condition will be censored during final follow up."
What potential health hazards might accompany the use of SOC + TSC-101?
"Assessed on a scale from 1-3, our team at Power deemed the safety of SOC + TSC-101 to be a 1 due to its Phase 1 status which implies that there is only preliminary evidence for both efficacy and security."
What is the capacity of the clinical trial with regards to participants?
"Affirmative. The data hosted on clinicaltrials.gov says this medical experiment, initially made available to the public on November 1st 2022 is currently looking for participants. Altogether 63 individuals need to be registered from 5 different hospitals."
Is there availability for individuals to join this experiment?
"As per the details on clinicaltrials.gov, this investigation is currently recruiting participants. The trial was made public on November 1st 2022 and received its latest update on November 15th 2022."
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