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Pyrimidine Analog
Selinexor Combination Therapy for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Timothy Pardee
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Laboratory values ≤2 weeks must be: AST(SGOT)/ALT(SGPT)≤ 2.5 X institutional upper limit of normal, Bilirubin ≤ 2 X ULN (3X if known history of Gilbert's syndrome), Creatinine clearance (CrCl) must be > 20 mL/min, Baseline left ventricular ejection fraction of at least 40% by MUGA or ECHO.
Patients with de novo AML must not have partial or total monosomy 5 or 7 or i(17q) or t(17p). Negative FISH studies are sufficient for enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat acute myeloid leukemia in older patients. The new combination includes a drug that may stop the growth of tumor cells.
Who is the study for?
This trial is for adults over 18 with newly diagnosed Acute Myeloid Leukemia (non-APL) who haven't had AML treatment, except Hydrea and ATRA. It's not for those with certain genetic abnormalities or previous cancer treatments, HIV, hepatitis, CNS involvement, or other serious health issues. Participants must be physically able to undergo therapy and willing to use effective contraception.Check my eligibility
What is being tested?
The trial tests Selinexor combined with chemotherapy drugs cytarabine and daunorubicin hydrochloride in older patients. The goal is to see if this mix can better kill leukemia cells by blocking enzymes needed for cell growth while stopping the cells from dividing or spreading.See study design
What are the potential side effects?
Selinexor may cause nausea, vomiting, diarrhea, loss of appetite, weight loss; blood disorders like anemia; fatigue; liver enzyme changes. Chemotherapy drugs can lead to hair loss, mouth sores, increased infection risk due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My acute myeloid leukemia does not have specific genetic changes (no monosomy 5 or 7, i(17q), t(17p)).
Select...
I am using two forms of birth control and have a negative pregnancy test, or I use effective contraception if I am a sexually active male.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events version 4.0
Progress-free survival
Rate of allogeneic stem cell transplantation
+1 moreSide effects data
From undefined Phase 3 trial • 1734 Patients • NCT0002525980%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Depression
1%
Hyponatremia
1%
Immune system disorders - Other, specify
1%
Hypoxia
1%
Myalgia
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 (Selinexor) cytarabine, daunorubicin and selinexorExperimental Treatment3 Interventions
INDUCTION: Cytarabine IV on days 1-7, daunorubicin hydrochloride IV on days 1-3, and selinexor PO twice weekly from day 1. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
RE-INDUCTION: Disease has not responded receive cytarabine IV on days 1-5, daunorubicin hydrochloride IV on days 1-2, and selinexor PO twice weekly. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: In remission receive cytarabine IV every 12 hours for a total 6 doses days 1-3, and selinexor PO twice weekly from day 1. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Group II: Standard of Care - Cytarabine and daunorubicinActive Control2 Interventions
INDUCTION: Cytarabine IV on days 1-7, daunorubicin hydrochloride IV on days 1-3. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
RE-INDUCTION: Disease has not responded receive cytarabine IV on days 1-5, daunorubicin hydrochloride IV on days 1-2. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: In remission receive cytarabine IV every 12 hours for a total 6 doses days 1-3. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Selinexor
2020
Completed Phase 2
~1360
Cytarabine
2016
Completed Phase 3
~3310
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,626 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,905 Total Patients Enrolled
Timothy PardeePrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot swallow pills or have a condition affecting how my body absorbs medication.I have another cancer that needs treatment, not including skin cancer.I have had chemotherapy with stem cell support in the last 6 months.I have a new diagnosis of Acute Myeloid Leukemia and haven't started treatment, except possibly Hydrea or ATRA.I am taking hydroxyurea or cytarabine for leukocytosis without severe side effects.I have only used hydroxyurea or ATRA for my AML, or I haven't received any treatment.I have AML that developed after previous cancer treatments, but I may have had MDS treated with a specific agent.I haven't had cancer treatment or fully recovered from its side effects in the last 4 weeks.I do not have cancer that has spread to my brain or spinal cord.I have AML without prior cancer treatments, except for MDS treated with a hypomethylating agent.My acute myeloid leukemia does not have specific genetic changes (no monosomy 5 or 7, i(17q), t(17p)).I am using two forms of birth control and have a negative pregnancy test, or I use effective contraception if I am a sexually active male.I do not have HIV or hepatitis.I have previously been treated with a SINE compound.I am older than 18 years.I am physically able to care for myself and my doctor believes I can handle strong cancer treatment.I am under 60 and my cancer does not have FLT3 mutations, or I am over 60.You have had allergic reactions to similar drugs or substances like selinexor in the past.I do not have any uncontrolled illnesses like heart failure or irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care - Cytarabine and daunorubicin
- Group 2: Arm 2 (Selinexor) cytarabine, daunorubicin and selinexor
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please outline the risks associated with Cytarabine?
"Although there is some evidence that Cytarabine is safe, it is only supported by data from Phase 2 trials."
Answered by AI
Do you know of any other research studies that have used Cytarabine?
"Currently, there are 322 ongoing studies related to Cytarabine. Out of those, 71 have reached Phase 3 clinical trials. New york, New York has the highest concentration of research teams running these tests; however, there are 13360 total locations where these medical experiments are taking place."
Answered by AI
What indications does Cytarabine commonly address?
"Acute myelocytic leukemia is most often treated with Cytarabine. However, this medication can also be used to treat other conditions including blast phase chronic myelocytic leukemia, lymphoma, and refractory multiple myeloma."
Answered by AI
Are we still recruiting individuals for this project?
"That is correct, the trial detailed on clinicaltrials.gov is recruiting patients. The posting date was February 2nd, 2018 with the most recent update happening on May 20th, 2022. They are 100 individuals needed to complete the study at a single site."
Answered by AI
How large is the study's sample size?
"That is correct. The information available on clinicaltrials.gov indicates that this trial is currently looking for participants. This study was originally posted on February 2nd, 2018 and was last updated on May 20th, 2022. They are hoping to recruit 100 patients from 1 site."
Answered by AI
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