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PARP Inhibitor
Olaparib for Acute Myeloid Leukemia with IDH Mutation
Phase 2
Waitlist Available
Led By Thomas Prebet
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
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.
Who is the study for?
Adults diagnosed with relapsed or refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with an IDH mutation, who have tried first-line therapy without success. Participants must be in stable health otherwise, not pregnant, and willing to use contraception. Those with uncontrolled infections, other active cancers needing treatment, or known hypersensitivity to olaparib are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Olaparib for patients whose AML or MDS has returned after treatment or hasn't responded at all. The study aims to determine if Olaparib can block enzymes that cancer cells need to grow and whether it's better than standard chemotherapy.See study design
What are the potential side effects?
Olaparib may cause side effects like nausea, fatigue, blood cell count changes leading to increased infection risk, shortness of breath, headaches and dizziness. Some people might experience more serious issues affecting their lungs or kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hepatitis B virus is under control with treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My MDS is classified as intermediate, high, or very high risk with excess blasts.
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I am HIV-positive, on treatment, and my viral load is undetectable.
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I finished chemotherapy 3 weeks ago and radiotherapy 2 weeks ago.
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My cancer has a specific IDH2 mutation.
Select...
My MDS is classified as intermediate, high, or very high risk with excess blasts.
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I am 18 years old or older.
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My cancer has a specific IDH1 mutation.
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My AML or MDS has not responded to the first treatment or has come back after it.
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I have been diagnosed with MDS or AML according to WHO 2016 guidelines.
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My AML or MDS has not responded to or has returned after initial treatment.
Select...
I had a stem cell transplant over 6 months ago, have minimal GVHD, and stopped immunosuppressants 2 weeks ago.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I have been diagnosed with MDS or AML according to WHO 2016 guidelines.
Select...
I am 18 years old or older.
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My hepatitis B virus load is undetectable with treatment.
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I had hepatitis C but have been treated and cured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative ORR
Overall response rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events
Overall survival (OS)
+1 moreOther outcome measures
Change in 2-hydroxyglutarate (2HG) levels
Minimal residual disease (MRD) assessment
Mutant allele frequency
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib)Experimental Treatment3 Interventions
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Olaparib
2007
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,270 Total Patients Enrolled
Thomas PrebetPrincipal InvestigatorYale University Cancer Center LAO
Rory M ShallisPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (olaparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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