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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.

Must not have

Patients unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI dysfunction that could interfere with absorption of study treatment

Patients with another active malignancy that requires treatment excluding non-melanoma skin cancers.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My acute myeloid leukemia does not have specific genetic changes (no monosomy 5 or 7, i(17q), t(17p)).

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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.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills or have a condition affecting how my body absorbs medication.

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I have another cancer that needs treatment, not including skin cancer.

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I have had chemotherapy with stem cell support in the last 6 months.

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I have only used hydroxyurea or ATRA for my AML, or I haven't received any treatment.

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I haven't had cancer treatment or fully recovered from its side effects in the last 4 weeks.

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I do not have cancer that has spread to my brain or spinal cord.

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I do not have HIV or hepatitis.

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I have previously been treated with a SINE compound.

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I do not have any uncontrolled illnesses like heart failure or irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Secondary study objectives

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 more

Side effects data

From undefined Phase 3 trial • 1734 Patients • NCT00025259

80%

Neutrophil count decreased

42%

Anemia

31%

Platelet count decreased

26%

Febrile neutropenia

18%

White blood cell decreased

16%

Infections and infestations - Other, specify

Blood and lymphatic system disorders - Other, specify

Lymphocyte count decreased

Catheter related infection

Dehydration

Abdominal pain

Mucositis oral

Vomiting

Anaphylaxis

Hypokalemia

Hypotension

Hyponatremia

Hypoxia

Myalgia

Depression

Immune system disorders - Other, specify

Dizziness

Constipation

Esophagitis

Ileus

Pain

Carbon monoxide diffusing capacity decreased

Hypoalbuminemia

Neuralgia

Peripheral sensory neuropathy

Dyspnea

Diarrhea

Typhlitis

Hyperglycemia

Headache

Seizure

Syncope

Nausea

Cardiac disorders - Other, specify

Hypophosphatemia

Bone pain

Peripheral motor neuropathy

Thromboembolic event

Hypertension

100%

80%

60%

40%

20%

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5330

Selinexor

2020

Completed Phase 3

~1730