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Acute Myeloid LeukemiaPhase 1/2NCT02270463

SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission

A Phase 1/2 study testing Tagraxofusp-erzs in people with Acute Myeloid Leukemia, run by Stemline Therapeutics, Inc. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a non-randomized, open-label, multicenter, dose escalation study designed to determine the maximum tolerated dose (MTD) of SL-401 in adult patients with acute myeloid leukemia, and to evaluate the safety profile of SL-401 at the MTD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Tagraxofusp-erzs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
7 sitesUnited States
Study dates
Feb 2015to Dec 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • The patient has a diagnosis of AML according to World Health Organization (WHO) criteria.
  • The patient received any induction chemotherapy regimen and may have received post-remission consolidation therapy prior to screening.
  • The patient has achieved a first or second CR or CRi. For patients without evidence of MRD in CR/CRi, CR (or CRi) must have been initially identified within 12 months prior to screening.
  • OR The patient has achieved first or second CR or CRi with evidence of MRD as determined locally at least 6 months post stem cell transplant without evidence of acute or chronic graft-versus-host disease post-transplant and has not received immunosuppressant therapy for at least 14 days prior to SL-401 therapy.
  • The patient has adverse risk disease or AML for which there is otherwise a substantial risk of relapse, which includes but is not limited to: adverse karyotype, FLT3 internal tandem duplication (ITD) mutation, history of antecedent hematologic disorder (AHD), therapy-related AML, history of requiring more than 1 cycle of intensive induction chemotherapy to achieve first remission, and/or presence of persistent MRD (detected by cytogenetics, molecular markers, or flow cytometry) at any point after the initial induction cycle.
  • For patients enrolling in Stage 2, the bone marrow evaluation determined locally within the previous 6 months indicates the presence of MRD.
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  • The patient is not considered to be an immediate candidate for allogeneic stem cell transplant as determined by the investigator.
  • The patient is ≥18 years old.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0-2.
  • The patient has adequate organ function, including cardiac, renal, and hepatic function:
  • Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiography (ECHO) within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG)
  • Serum creatinine ≤1.5 mg/dL
  • Serum albumin ≥3.2 g/dL in the absence of receipt of (IV) albumin within the previous 72 hours.
  • Bilirubin ≤1.5 mg/dL
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × the upper limit of normal (ULN)
  • Creatine phosphokinase (CPK) ≤2.5 × the ULN.
  • The patient has adequate bone marrow reserve:
  • Absolute neutrophil count (ANC) > 0.5 × 10^9/L
  • The patient is a woman of child bearing potential (WOCBP) who has had a negative serum or urine pregnancy test within 1 week prior to SL-401 treatment (intervals shorter than 1 week are acceptable if required by institutional guidelines).
  • A written and voluntarily signed informed consent must be obtained from the patient or legally authorized representative, in accordance with local regulations, before the initiation of any study related procedures. The patient or legally authorized representative must be able to read and understand the informed consent form (ICF).
  • The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment.
  • The patient (male and female) agrees to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for 2 months after the last infusion of SL-401.

Who cannot join

  • The patient has a diagnosis of AML associated with karyotype t(15;17).
  • The patient has persistent and clinically significant Grade ≥2 toxicities from induction or consolidation therapy (excluding alopecia, nausea, fatigue, and liver function tests [as mandated in the inclusion criteria]) not readily managed with supportive measures.
  • The patient received treatment with another investigational agent within 14 days of screening.
  • The patient previously received treatment with SL-401.
  • The patient has an active malignancy and/or cancer history (excluding AML or antecedent myelodysplastic syndrome [MDS]) that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) with substantial potential for recurrence and/or ongoing active malignancy must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease.
  • The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
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  • The patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study.
  • The patient has known active or suspected central nervous system (CNS) leukemia. If suspected, CNS leukemia should be ruled out with relevant imaging and/or examination of cerebrospinal fluid.
  • The patient has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation (DIC), or psychiatric illness/social situations that would limit compliance with study requirements.
  • The patient is pregnant or breast feeding.
  • The patient has known positive status for human immunodeficiency virus (HIV), active or chronic Hepatitis B or Hepatitis C.
  • The patient is oxygen-dependent.
  • The patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Fred Hutchinson Cancer Research Institute

    Seattle, Washington, 98101

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 12902

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Phase 1/2 Study of SL-401 as Consolidation Therapy for Adult Patients With Adverse Risk Acute Myeloid Leukemia in First CR, and/or Evidence of Minimal Residual Disease (MRD) in First CR

This is a non-randomized, open-label, multicenter, dose escalation study designed to determine the maximum tolerated dose (MTD) of SL-401 in adult patients with acute myeloid leukemia, and to evaluate the safety profile of SL-401 at the MTD.

Read the detailed description

Patients who were in their first or second complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi) after induction therapy were treated with SL-401, which was administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or more cycles. Stage 1 consisted of a period in which patients were treated with SL-401 at 3 dose levels. During Stage 2, patients with minimal residual disease (MRD) in their bone marrow were treated at a MTD or maximum tested dose in which multiple dose-limiting toxicities were not observed (identified in Stage 1).

Being tested
Tagraxofusp-erzs
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • Tagraxofusp-erzsDrug

    Also called SL-401

    Tagraxofusp-Erzs administered by IV infusion at doses of 7, 9, and 12 µg/kg/day

Study groups in NCT02270463
Study groupRoleWhat they receive
Tagraxofusp-erzsExperimentalPatients received tagraxofusp-erzs (SL-401) by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in both stages.
Receives: Drug: Tagraxofusp-erzs

What is being measured

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

  1. Dose-Limiting Toxicity (DLT)

    The maximum tolerated dose was defined as the dose preceding the dose level at which 2 or more patients experienced a DLT during treatment Cycle 1.

    Measured: 24 weeks

Secondary outcomes (3)

  1. Eradication of Minimal Residual Disease (MRD) From Baseline

    The rate of MRD eradication (conversion) is defined as the proportion of patients with evidence of MRD prior to initial therapy with investigational SL-401 for whom MRD cannot be detected upon subsequent (post treatment) assessments.

    Measured: 24 weeks

  2. Overall Survival (OS)

    OS is defined as the time from the date of first infusion of SL-401 to the date of death from any cause. Participants still alive or lost to follow-up at the time of analysis were censored on the last date known to be alive prior to the analysis cutoff date, as determined by in-person visit or telephone contact.

    Measured: Day 1 (enrollment) through Month 44

  3. Relapse-Free Survival (RFS)

    RFS is defined as the proportion of patients who remain free of acute myeloid leukemia recurrence (hematologic) and alive.

    Measured: 24 weeks

Timeline

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

  1. First posted21 Oct 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270463
Sponsor's protocol ID
STML-401-0214
Status last verified
Oct 2024
First submitted
9 Oct 2014
Last updated
17 Oct 2024
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tagraxofusp-erzs in people with Acute Myeloid Leukemia, run by Stemline Therapeutics, Inc. at 7 sites in United States.

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 22 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose-Limiting Toxicity (DLT) (time frame: 24 weeks). 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 NCT02270463.

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 17 Oct 2024.

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