Untreated Adult Acute Myeloid LeukemiaPhase 2NCT02835222

Selinexor With Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients

A Phase 2 study testing Cytarabine, Daunorubicin Hydrochloride and Selinexor in people with Untreated Adult Acute Myeloid Leukemia, run by Wake Forest University Health Sciences at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Untreated Adult Acute Myeloid Leukemia
What is being tested?: Cytarabine, Daunorubicin Hydrochloride and Selinexor
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 2 sitesUnited States
Study dates: 2 Feb 2018to 18 Apr 2027
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have histologically or cytologically documented newly diagnosed de novo Acute Myeloid Leukemia (non-APL) that has not yet been treated. Hydrea,cytarabine and ATRA previous treatments are acceptable.
Patients with core binding factor acute myeloid leukemia (AML) (ie AML with t(8;21) or t(16;16) or i16) are not eligible.
Patients must not have a secondary AML (defined as a history of prior radiation therapy or systemic chemotherapy, CMML or MDS not treated with a hypomethylating agent) however history of previous MDS treated with a hypomethylating agent IS allowed.
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 (i.e. FISH for -5, -7, +8, inv(16), t(8;21) and 17p).
Patients must not have mutated FLT3 (either ITD OR TKD mutations).
Hydroxyurea, leukapheresis or cytarabine may be used to control leukocytosis, provided that it is without Grade >2 non-hematologic toxicity, and can be taken until start of therapy.

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Age >18 years.
ECOG performance status of ≤ 2 and fit for induction therapy in the opinion of the treating physician.
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'syndrome)
Creatinine clearance (CrCl) must be > 20 mL/min
Baseline left ventricular ejection fraction of at least 40% by MUGA or ECHO.
Female patients of childbearing potential must agree to use 2 methods of contraception (including 1 highly effective and 1 effective method of contraception) and have a negative serum pregnancy test at Screening. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
Ability to understand and the willingness to sign an IRB-approved informed consent document.

Who cannot join

Patients who have received any therapy other than hydroxyurea, cytarabine or ATRA with the purpose of treating their AML or patients with core binding factor AML or Acute Promyelocytic Leukemia are not eligible.
Patients with a secondary AML (defined as a history of prior radiation therapy or systemic chemotherapy, CMML or MDS not treated with a hypomethylating agent) however history of previous MDS treated with a hypomethylating agent IS allowed.
Patients having received prior radiotherapy, treatment with cytotoxic agents, treatment with biologic agents or any anti-cancer therapy for a non-AML malignancy within the 4 weeks prior to treatment with selinexor, or those who have not fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment).
Patients with another active malignancy that requires treatment excluding non-melanoma skin cancers.
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months.
Patients with known central nervous system involvement should be excluded from this clinical trial because the penetration of selinexor into the CNS is not currently known.

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History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor.
Uncontrolled concurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements.
Patients with known HIV infection or hepatitis (Note: Patients with known HIV infection are excluded because patients with an immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.
Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.
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
Prior exposure to a SINE compound

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: An Investigator-Sponsored Randomized Phase II Study of Selinexor in Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients

This pilot phase II trial studies how well selinexor works when given together with induction, consolidation, and maintenance therapy in treating older patients with acute myeloid leukemia. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selinexor with induction, consolidation, and maintenance therapy may kill more cancer cells in older patients with acute myeloid leukemia.

Read the detailed description

PRIMARY OBJECTIVES:

To compare the overall survival of patients receiving the proposed study regimen versus standard of care (defined as time from randomization to death from any cause).

SECONDARY OBJECTIVES:

To compare the response rate (Complete remission (CR), complete remission with incomplete count recovery (CRi) as per Dhoner et. al.) of patients receiving the proposed study regimen versus standard of care (SOC).

II To compare disease free survival in patients receiving the proposed study regimen vs standard of care (defined as time from randomization to relapse or death from any cause).

III. To assess the rate of allogeneic stem cell transplantation

IV. To compare the toxicity of the proposed study regimen vs standard of care.

OUTLINE:

INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7, daunorubicin hydrochloride IV on days 1-3, and selinexor orally (PO) twice weekly from day 1. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.

RE-INDUCTION THERAPY: Patients whose 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 THERAPY: Patients in remission receive cytarabine IV every 12 hours on 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.

After completion of study treatment, patients are followed up for 14 days and then every 3 months for up to 1 year.

Conditions: Untreated Adult Acute Myeloid Leukemia
Being tested: Cytarabine, Daunorubicin Hydrochloride, Selinexor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CytarabineDrug
Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
Given IV
Daunorubicin HydrochlorideDrug
Also called Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin
Given IV
SelinexorDrug
Also called CRM1 Nuclear Export Inhibitor KPT-330, KPT-330, Selective Inhibitor of Nuclear Export KPT-330, SINE KPT-330
Given PO

Study groups in NCT02835222
Study group	Role	What they receive
Arm 2 (Selinexor) cytarabine, daunorubicin and selinexor	Experimental	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. Receives: Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Selinexor
Standard of Care - Cytarabine and daunorubicin	Active comparator	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. Receives: Drug: Cytarabine; Drug: Daunorubicin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
Kaplan-Meier estimation will be used to analyze the overall survival. Overall survival (OS) is measured from the date of randomization to the date of death due to any cause. Participants will be monitored for survival through routine follow-up visits.
Measured: Up to 1 year

Secondary outcomes (4)

Response rate of complete remission (CR) or complete remission with incomplete recovery (CRi)
Confidence intervals will be calculated around the estimates of the response rate (complete remission and complete remission with incomplete recovery).
Complete remission (CR): Defined by the absence of leukemia cells in the blood and bone marrow.
Partial remission with incomplete hematologic recovery (CRi): This is a more stringent criterion, requiring a normal platelet count along with a normal ANC.
Measured: Up to 1 year
Progression-free survival
Kaplan-Meier survival analysis methods to compare time to progression.
Measured: Up to 1 year
Rate of allogeneic stem cell transplantation
Fisher's exact tests to compare rates.
Measured: Up to 1 year
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events version 4.0
The frequency of toxicities experienced by the participants will be presented by type and grade in an effort to monitor and report safety of the treatment.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 201818 Apr 2027

First posted18 Jul 2016 (estimated)
Study start2 Feb 2018
Primary completion18 Apr 2027 (estimated)
Study completion18 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Untreated Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02835222
Sponsor's protocol ID: IRB00039092
Other IDs: NCI-2016-00951, CCCWFU 22316, P30CA012197
Status last verified: Aug 2026
First submitted: 7 Jul 2016
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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