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Talazoparib for Leukemia
Study Summary
This trial is testing if Talazoparib is an effective treatment for patients with AML or MDS that have a mutation in the cohesin complex.
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 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777Trial Design
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Who is running the clinical trial?
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- I can take care of myself but might not be able to do heavy physical work.I have had treatments for MDS/AML with no restrictions and am over 2 months post-stem cell transplant, not on immunosuppressants for 14 days.My MDS/AML has not improved after 2 treatments with specific medications.I have leukemia that has spread to my brain.I am 18 years old or older.I have secondary AML not recommended for any approved AML therapy.I am not pregnant or breastfeeding.My kidneys are functioning well.I agree to use effective birth control during and up to 4 months after the study.I have AML or MDS and cannot undergo intensive chemotherapy.I do not have any serious illnesses that my doctor thinks could interfere with the study.I have a high-risk type of a blood disorder (MDS) needing treatment, but not immediate transplant or intensive chemotherapy.I agree to use effective birth control during and up to 4 months after the study.My organs are functioning normally.My doctor says I can't have strong chemotherapy and I have a specific diagnosis.I have never taken PARP inhibitors for any condition.My blood or bone marrow has 5% or more cancer cells.My test shows a specific genetic change in my cancer.I am 18 years old or older.I haven't had leukemia treatment in the last 2 weeks and have recovered from most side effects.I can take care of myself but might not be able to do heavy physical work.My AML has returned or didn't respond to treatment, and I can't have standard AML therapy.My MDS didn't respond or got worse after treatment with decitabine or azacitidine.I have an active HIV, HCV, or HBV infection.I had cancer before but it's either in remission or not currently active.
- Group 1: Talazoparib Part I
- Group 2: Talazoparib + Decitabine Part II
- 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
What level of hazard is associated with Talazoparib administration?
"Due to its status as a Phase 1 trial, with limited safety and effectiveness data available, Talazoparib's risk profile can be rated at just 1."
What is the scope of participation for this clinical research endeavor?
"Affirmative, the information on clinicaltrials.gov shows that this research project is looking for individuals to partake in their study. This particular trial was initially posted on August 1st 2019 and recently updated on July 5th 2022. They require 12 volunteers at 2 different medical centres."
Are there any open slots available for participation in this clinical trial?
"Indeed, per the latest update on clinicaltrials.gov, this medical trial is still recruiting for 12 participants across two centres. The initial posting of the study was made on August 1st 2019 and has been updated as recently as July 5th 2022."
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