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Olaparib for Acute Myeloid Leukemia with IDH Mutation
Study Summary
This trial is studying how well olaparib works in treating patients with AML or MDS that has relapsed or is refractory. Olaparib may stop cancer cell growth by blocking enzymes needed for cell growth.
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 2023 Phase 3 trial • 154 Patients • NCT02184195Trial Design
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Who is running the clinical trial?
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- My cancer has an IDH1 or IDH2 mutation, confirmed within the last 30 days.I can take care of myself but might not be able to do heavy physical work.I cannot take pills by mouth or have stomach issues that affect medication absorption.I am currently undergoing chemotherapy, radiation, or immunotherapy for AML/MDS.My MDS is classified as intermediate, high, or very high risk with excess blasts.I am HIV-positive, on treatment, and my viral load is undetectable.I may or may not have been treated with IDH targeted therapies before.My liver tests are within normal limits, or high due to leukemia.I will use a condom during and for 3 months after treatment if my partner could become pregnant.I have been on a stable dose of up to 20 mg prednisone daily for at least 4 weeks.I have never been treated with a PARP inhibitor like olaparib.I do not have any other cancers that need treatment which would interfere with this study.I finished chemotherapy 3 weeks ago and radiotherapy 2 weeks ago.My hepatitis B virus is under control with treatment.You are currently breastfeeding.You are currently taking part in another study that involves experimental drugs.My cancer has a specific IDH2 mutation.My MDS is classified as intermediate, high, or very high risk with excess blasts.I do not have any ongoing, untreated infections.I am not taking strong or moderate CYP3A inhibitor medications.I had major surgery more than 2 weeks ago and have recovered from it.My brain or spinal cord disease is causing symptoms and is not under control.I am 18 years old or older.My cancer has a specific IDH1 mutation.I have heart issues that are not under control or I was born with a condition that affects my heart's rhythm.I have lasting side effects from cancer treatment, but not hair loss.I am not taking any strong or moderate drugs that affect liver enzymes.I may or may not have been treated with IDH targeted therapies before.I do not have any serious, uncontrolled health conditions or infections.My AML or MDS has not responded to the first treatment or has come back after it.I have active leukemia in my brain or need ongoing chemotherapy in my spine.I am HIV positive, on treatment, and my viral load is undetectable.I haven't had chemotherapy or radiotherapy for 3 weeks, except for pain relief.I have been diagnosed with MDS or AML according to WHO 2016 guidelines.My AML or MDS has not responded to or has returned after initial treatment.I had a stem cell transplant over 6 months ago, have minimal GVHD, and stopped immunosuppressants 2 weeks ago.I had hepatitis C but am cured, or I'm being treated with no detectable virus.My doctor will decide my treatment based on specific genetic changes in my cancer.My low blood count and need for transfusions are because of my MDS/AML.I have been diagnosed with MDS or AML according to WHO 2016 guidelines.I have recovered from side effects of my previous cancer treatments.I have been diagnosed with acute promyelocytic leukemia.I am 18 years old or older.My hepatitis B virus load is undetectable with treatment.I had hepatitis C but have been treated and cured.You are allergic to olaparib or any of the ingredients in the medication.I have had a double umbilical cord blood transplant before.
- Group 1: Treatment (olaparib)
- 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
Has Olaparib been sanctioned by the FDA?
"Olaparib's safety is estimated at a 2 since Phase 2 trials provide limited evidence of its efficacy but robust proof that it can be used without risk."
Has this experimental research been done before?
"Olaparib has been studied extensively; with 189 ongoing studies in 1470 cities and 60 countries. AstraZeneca first tested the drug on 98 patients back in 2005, successfully completing Phase 1 approval trials. Since then, 63 clinical investigations have concluded their results."
What other research studies have been conducted exploring the efficacy of Olaparib?
"Currently, 189 clinical trials are being performed investigating Olaparib; 27 of these studies are in the third phase. Houston, Texas is hosting most of those experiments yet globally there exist 9265 sites that offer access to this drug therapy."
Are there any opportunities currently available to participate in this experiment?
"Affirmative. As detailed on clinicaltrials.gov, this trial is actively recruiting 94 participants from 9 separate medical centres. The original posting date was March 9th 2020 and the most recent update took place December 3rd 2022."
Could you provide an estimate of the number of individuals currently participating in this experiment?
"This research requires 94 volunteers who meet the prerequisites to take part. UM Sylvester Comprehensive Cancer Center at Deerfield Beach in Deerfield Beach, North carolina and UM Sylvester Comprehensive Cancer Center at Coral Gables in Coral Gables, Connecticut are both sites that offer participation opportunities for patients."
What medical applications does Olaparib predominantly target?
"Olaparib is typically utilized as a form of advanced intervention. It can also be beneficial in treating malignant neoplasms of the ovary, primary peritoneal cancer, auditory and tactile hallucinations, as well as somatic disorders."
Are there numerous healthcare centers conducting this experiment in Canada?
"The primary institutions hosting this clinical trial are the UM Sylvester Comprehensive Cancer Center at Deerfield Beach in North carolina, the UM Sylvester Comprehensive Cancer Center at Coral Gables in Connecticut and the University of Miami Miller School of Medicine-Sylvester Cancer Center located in California. Additional sites can be found across 9 other states."
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