Acute Myeloid LeukemiaPhase 1FLAGINEXORNCT03661515

Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML

A Phase 1 study testing Selinexor, fludarabine and idarubicin in people with Acute Myeloid Leukemia, run by PETHEMA Foundation at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This protocol corresponds to a multicenter, open-label, non-randomized, phase I study designed to determine the safety of the combination of selinexor with chemotherapy in young patients with relapsed or refractory AML. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Selinexor, fludarabine and idarubicin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 4 sitesSpain
Study dates: 17 Jul 2018to 15 Oct 2019
Phase: Phase 1
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
Age ≥ 18, and ≤ 65 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Diagnosis of AML (defined using WHO criteria) of any type except for acute promyelocytic leukemia (APL; AML M3).
Relapsing or refractory AML, defined as either:
Recurrence of disease after first CR (duration of CR ≤ 24 months), or Failure to achieve CR or CRi after 1 or 2 identical induction cycles containing an anthracycline plus cytarabine based schedule.

Show all 9Show fewer

No contraindications to receive intensive chemotherapy.
Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use two reliable methods of contraception for three months after their last dose of medication. Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential).
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.

Who cannot join

Patients with APL/AML M3.
Patients who are pregnant or lactating.
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1 or radio-immunotherapy 4 weeks prior to Cycle 1 Day 1. Hydroxyurea is permitted until 1 day prior to Cycle 1 Day 1.
Previous treatment with a SINE compound.
Major surgery within 2 weeks of first dose of study drug.
Any life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.

Show all 15Show fewer

Unstable cardiovascular function:
Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree AV block or asymptomatic LAFB/RBBB will not be excluded), or congestive heart failure (CHF) of NYHA Class ≥ 3, or myocardial infarction (MI) within 3 months.
Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.
Active hepatitis B or hepatitis C infection.
Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study).
Patients unable to swallow tablets, patients with malabsorption syndrome, or any other gastrointestinal (GI) disease or GI dysfunction that could interfere with absorption of study treatment.
Any of the following laboratory abnormalities unless due to leukemia:
Hepatic dysfunction: bilirubin > 2.0 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome: total bilirubin of > 3 x ULN) and alanine aminotransferase (ALT) and aspartic aminotransferase (AST) > 2.5 times ULN or in case of liver metastases: In patients with known liver involvement of their cancer, AST and ALT > 5 x ULN.
Severe renal dysfunction: estimated creatinine clearance of < 30 mL/min, measured in 24 hour urine or calculated using the formula of Cockroft and Gault: (140-Age) x Mass (kg)/[72 x creatinine (mg/dL)]; multiply by 0.85 if female

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

Hospital Germans Tries i Pujol, Badalona
Badalona
Hospital San Pedro de Alcántara,
Cáceres
Hospital Universitario 12 de Octubre,
Madrid
Hospital la Fe
Valencia

Other trials in Spain

About this study

Official title: An Investigator Sponsored Phase I Trial of Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML

The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a phase I design in which es-calating doses of selinexor will be given to 3 groups, each with 3-6 patients until achieving the maximum tolerated dose (MTD).

Read the detailed description

Study Design:

Each cycle (second induction, consolidation or maintenance) of treatment will compromise 3 weeks of selinexor treatment, and at least one week off treatment. The new cycle will not start if there is an ongoing grade 3 or higher non-hematologic toxicity or persistent grade 3 neutropenia in patients achieving CR.

Study design allows a maximum of 18 patients.

Induction cycle (up to 2 cycles):

Treatment will consist of fludarabine 30 mg/m2/day intravenously on days 1 to 4, idarubicin 10 mg/m2/day intravenously on days 1 to 3, cytarabine 2 g/m2/day intravenously on days 1 to 4, G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5. This schedule will be combined with oral selinexor (KPT-330) for three weeks at days and dose according to escalation level:

Level -1: Selinexor 40 mg/day, once weekly
Level 1: Selinexor 60 mg/day, once weekly
Level 2: Selinexor 80 mg/day, once weekly
Level 3: Selinexor 100 mg/day, once weekly If a partial response is obtained after the first cycle of treatment, an identical induction therapy will be administered.

If a patient achieves a complete remission after 1 or 2 cycles of FLAG-IDA plus selinexor, allogeneic stem cell transplantation (Allo-SCT) will be attempted. If Allo-SCT is not possible, this patient will receive consolidation treatment as described below.

Consolidation cycle (up to 2 cycles):

Treatment will consist of cytarabine 1 g/m2/day intravenously (3 hours) on days 1 to 6. This schedule will be combined with oral selinexor (the same dosage that was administered to the patient in the induction cycle).

At most, patients will receive up to 4 cycles of combined chemotherapy.

Maintenance cycle:

For patients in CR, and when an Allo-SCT is not feasible, a maintenance treatment with selinexor could be started for up to 6 cycles.

Selinexor will be given at the same level as during induction therapy in cycles of four weeks (3 weeks on selinexor and 1 week off).

Conditions: Acute Myeloid Leukemia
Being tested: Selinexor, fludarabine, idarubicin, cytarabine, G-CSF
Keywords: Acute Myeloid Leukemia, Relapsed, Refractory, Selinexor
Medical subject headings: Leukemia, Myeloid, Acute, Recurrence

What participants receive

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

SelinexorDrug
According to escalation level:
- Level -1: Selinexor 40 mg/day, once weekly
- Level 1: Selinexor 60 mg/day, once weekly
- Level 2: Selinexor 80 mg/day, once weekly
- Level 3: Selinexor 100 mg/day, once weekly
fludarabineDrug
fludarabine 30 mg/m2/day intravenously on days 1 to 4
idarubicinDrug
idarubicin 10 mg/m2/day intravenously on days 1 to 3
cytarabineDrug
cytarabine 2 g/m2/day intravenously on days 1 to 4
G-CSFDrug
G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5

Study groups in NCT03661515
Study group	Role	What they receive
Fludarabine-Idarubicine-Cytarabine- Selinexor	Experimental	fludarabine 30 mg/m2/day intravenously on days 1 to 4, idarubicin 10 mg/m2/day intravenously on days 1 to 3, cytarabine 2 g/m2/day intravenously on days 1 to 4, G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5. This schedule will be combined with oral selinexor (KPT-330) for three weeks at days and dose according to escalation level: * Level -1: Selinexor 40 mg/day, once weekly * Level 1: Selinexor 60 mg/day, once weekly * Level 2: Selinexor 80 mg/day, once weekly * Level 3: Selinexor 100 mg/day, once weekly Receives: Drug: Selinexor; Drug: fludarabine; Drug: idarubicin; Drug: cytarabine; Drug: G-CSF

What is being measured

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

Maximum tolerated dose (MTD) of selinexor in combination with FLAG-Ida regimen
A standard 3 + 3 dose escalation schedule will be used for all escalations. Initially, three patients will be entered in each cohort at the scheduled starting dose level for that cohort. If a drug-related DLT (see Section 5.1.5.3) is not seen at the scheduled dose, the dose will be escalated for the subsequent group of 3 patients.
If 1 of 3 patients experiences a drug-related DLT, then 3 additional patients will receive that dose. If ≤ 2 of 6 patients experiences a drug-related DLT, the next scheduled dose level will be available. If, at a given dose level, > 2 patients experience a drug-related DLT, the MTD will have been exceeded, additional enrollment within that cohort will cease, and dose escalation will stop.
If a dose level proves intolerable (≥ 3 patients experience a DLT), enrollment will proceed at one dose-level lower.
Measured: At the end of Cycle 1 (each cycle is 56 days)
Find recommended phase 2 dose
A standard 3 + 3 dose escalation schedule will be used for all escalations. Initially, three patients will be entered in each cohort at the scheduled starting dose level for that cohort. If a drug-related DLT (see Section 5.1.5.3) is not seen at the scheduled dose, the dose will be escalated for the subsequent group of 3 patients.
If 1 of 3 patients experiences a drug-related DLT, then 3 additional patients will receive that dose. If ≤ 2 of 6 patients experiences a drug-related DLT, the next scheduled dose level will be available. If, at a given dose level, > 2 patients experience a drug-related DLT, the MTD will have been exceeded, additional enrollment within that cohort will cease, and dose escalation will stop.
If a dose level proves intolerable (≥ 3 patients experience a DLT), enrollment will proceed at one dose-level lower.
Measured: 3 months

Secondary outcomes (2)

Assessment of toxicity: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: 1 year
CR and CRi
antileukemic effects, including its ability to produce complete remissions, of Selinexor in combination with chemotherapy
Measured: 3 months

Timeline

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

17 Jul 201815 Oct 2019

First posted7 Sep 2018
Study start17 Jul 2018
Primary completion15 Jul 2019
Study completion15 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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 1
Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03661515
Sponsor's protocol ID: FLAGINEXOR: IST-ESP-000155
Acronym: FLAGINEXOR
Status last verified: May 2020
First submitted: 17 Jul 2018
Last updated: 20 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Martinez Sanchez MP, Megias-Vericat JE, Rodriguez-Veiga R, Vives S, Bergua JM, Torrent A, Suarez-Varela S, Boluda B, Martinez-Lopez J, Cano-Ferri I, Acuna-Cruz E, Torres-Minana L, Martin-Herreros B, Serrano A, Sempere A, Barragan E, Sargas C, Sanz M, Martinez-Cuadron D, Montesinos P; PETHEMA group. A phase I trial of selinexor plus FLAG-Ida for the treatment of refractory/relapsed adult acute myeloid leukemia patients. Ann Hematol. 2021 Jun;100(6):1497-1508. doi: 10.1007/s00277-021-04542-8. Epub 2021 Apr 29.
PubMed 33914097

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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All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigator Sponsored Phase I Trial of Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML
ClinicalTrials.gov ID: NCT03661515
Acronym / sponsor ID: FLAGINEXOR / FLAGINEXOR: IST-ESP-000155
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia, Relapsed, Refractory, Selinexor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: PETHEMA FoundationUniversity, hospital or other
Study start: 17 Jul 2018 (actual)
Primary completion: 15 Jul 2019 (actual)
Study completion: 15 Oct 2019 (actual)
First posted: 7 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design:

Study design allows a maximum of 18 patients.

Induction cycle (up to 2 cycles):

Level -1: Selinexor 40 mg/day, once weekly
Level 1: Selinexor 60 mg/day, once weekly
Level 2: Selinexor 80 mg/day, once weekly
Level 3: Selinexor 100 mg/day, once weekly If a partial response is obtained after the first cycle of treatment, an identical induction therapy will be administered.

Consolidation cycle (up to 2 cycles):

At most, patients will receive up to 4 cycles of combined chemotherapy.

Maintenance cycle:

For patients in CR, and when an Allo-SCT is not feasible, a maintenance treatment with selinexor could be started for up to 6 cycles.

Selinexor will be given at the same level as during induction therapy in cycles of four weeks (3 weeks on selinexor and 1 week off).

Study design

Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fludarabine-Idarubicine-Cytarabine- Selinexor	Experimental	Drug: Selinexor, Drug: fludarabine, Drug: idarubicin, Drug: cytarabine, Drug: G-CSFfludarabine 30 mg/m2/day intravenously on days 1 to 4, idarubicin 10 mg/m2/day intravenously on days 1 to 3, cytarabine 2 g/m2/day intravenously on days 1 to 4, G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5. This schedule will be combined with oral selinexor (KPT-330) for three weeks at days and dose according to escalation level: * Level -1: Selinexor 40 mg/day, once weekly * Level 1: Selinexor 60 mg/day, once weekly * Level 2: Selinexor 80 mg/day, once weekly * Level 3: Selinexor 100 mg/day, once weekly

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
Age ≥ 18, and ≤ 65 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Diagnosis of AML (defined using WHO criteria) of any type except for acute promyelocytic leukemia (APL; AML M3).
Relapsing or refractory AML, defined as either:

Key exclusion criteria (15 listed)

Patients with APL/AML M3.
Patients who are pregnant or lactating.
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1 or radio-immunotherapy 4 weeks prior to Cycle 1 Day 1. Hydroxyurea is permitted until 1 day prior to Cycle 1 Day 1.
Previous treatment with a SINE compound.
Major surgery within 2 weeks of first dose of study drug.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelinexorAccording to escalation level: * Level -1: Selinexor 40 mg/day, once weekly * Level 1: Selinexor 60 mg/day, once weekly * Level 2: Selinexor 80 mg/day, once weekly * Level 3: Selinexor 100 mg/day, once weekly	Drug	Fludarabine-Idarubicine-Cytarabine- Selinexor
fludarabinefludarabine 30 mg/m2/day intravenously on days 1 to 4	Drug	Fludarabine-Idarubicine-Cytarabine- Selinexor
idarubicinidarubicin 10 mg/m2/day intravenously on days 1 to 3	Drug	Fludarabine-Idarubicine-Cytarabine- Selinexor
cytarabinecytarabine 2 g/m2/day intravenously on days 1 to 4	Drug	Fludarabine-Idarubicine-Cytarabine- Selinexor
G-CSFG-CSF 300 mcg/m2/day subcutaneously from days -1 to 5	Drug	Fludarabine-Idarubicine-Cytarabine- Selinexor

Primary outcome

Maximum tolerated dose (MTD) of selinexor in combination with FLAG-Ida regimen
Time frame: At the end of Cycle 1 (each cycle is 56 days)
A standard 3 + 3 dose escalation schedule will be used for all escalations. Initially, three patients will be entered in each cohort at the scheduled starting dose level for that cohort. If a drug-related DLT (see Section 5.1.5.3) is not seen at the scheduled dose, the dose will be escalated for the subsequent group of 3 patients. If 1 of 3 patients experiences a drug-related DLT, then 3 additional patients will receive that dose. If ≤ 2 of 6 patients experiences a drug-related DLT, the next scheduled dose level will be available. If, at a given dose level, > 2 patients experience a drug-related DLT, the MTD will have been exceeded, additional enrollment within that cohort will cease, and dose escalation will stop. If a dose level proves intolerable (≥ 3 patients experience a DLT), enrollment will proceed at one dose-level lower.
Find recommended phase 2 dose
Time frame: 3 months
A standard 3 + 3 dose escalation schedule will be used for all escalations. Initially, three patients will be entered in each cohort at the scheduled starting dose level for that cohort. If a drug-related DLT (see Section 5.1.5.3) is not seen at the scheduled dose, the dose will be escalated for the subsequent group of 3 patients. If 1 of 3 patients experiences a drug-related DLT, then 3 additional patients will receive that dose. If ≤ 2 of 6 patients experiences a drug-related DLT, the next scheduled dose level will be available. If, at a given dose level, > 2 patients experience a drug-related DLT, the MTD will have been exceeded, additional enrollment within that cohort will cease, and dose escalation will stop. If a dose level proves intolerable (≥ 3 patients experience a DLT), enrollment will proceed at one dose-level lower.

2 secondary outcomes

Assessment of toxicity: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
CR and CRi
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
Derived from this study: PubMed 33914097Martinez Sanchez MP, Megias-Vericat JE, Rodriguez-Veiga R, Vives S, Bergua JM, Torrent A, Suarez-Varela S, Boluda B, Martinez-Lopez J, Cano-Ferri I, Acuna-Cruz E, Torres-Minana L, Martin-Herreros B, Serrano A, Sempere A, Barragan E, Sargas C, Sanz M, Martinez-Cuadron D, Montesinos P; PETHEMA group. A phase I trial of selinexor plus FLAG-Ida for the treatment of refractory/relapsed adult acute myeloid leukemia patients. Ann Hematol. 2021 Jun;100(6):1497-1508. doi: 10.1007/s00277-021-04542-8. Epub 2021 Apr 29.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selinexor, fludarabine and idarubicin in people with Acute Myeloid Leukemia, run by PETHEMA Foundation at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of selinexor in combination with FLAG-Ida regimen (time frame: At the end of Cycle 1 (each cycle is 56 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03661515, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.