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Acute Myeloid LeukemiaPhase 2ELPISNCT03435848

Efficacy and Safety of BST-236 in Newly Diagnosed Acute Myeloid Leukemia Patients, Unfit for Standard Induction Therapy

A Phase 2 study testing BST-236 in people with Acute Myeloid Leukemia, run by BioSight Ltd. at 16 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to assesses the benefit, safety, and pharmacokinetics (PK) of BST-236 in patients with newly-diagnosed Acute Myeloid Leukemia (AML) who are not eligible for standard induction chemotherapy due to advanced age or comorbidities. 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?
BST-236
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
16 sitesin 2 countries
Study dates
14 Aug 2018to 16 Mar 2023
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult ≥18 years of age
  • AML according to the 2016 revision to the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: ≥20% blasts in peripheral blood or marrow
  • de-novo AML or
  • AML secondary to MDS or
  • AML secondary to exposure to potentially leukemogenic therapies or agents (e.g. radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years
  • Not eligible for standard induction chemotherapy;
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  • Age ≥75 years or
  • Age ≥18 years with at least one of the following comorbidities:
  • Clinically significant heart or lung comorbidities, as reflected by at least one of:
  • Left ventricular ejection fraction (LVEF) ≤50%
  • Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected
  • Forced expiratory volume in 1 second (FEV1) ≤65% of expected ii. Chronic stable angina or congestive heart failure controlled with medication iii. Other contraindication(s) to anthracycline therapy (must be documented) iv. Other comorbidity that the Investigator judges as incompatible with intensive remission induction chemotherapy, which must be documented
  • Creatinine clearance (estimated by the Cockroft-Gault (C-G) or measured by 24 hours urine collection) ≥45 mL/min
  • Liver enzymes (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 times the upper limits of normal (ULN)
  • Total bilirubin ≤1.5 x ULN unless due to known history of Gilbert's disease
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening
  • Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study
  • Women of reproductive potential must have a negative serum pregnancy test within 48 hours of the first day of any BST-236 treatment course
  • Women or men of reproductive potential must use (or have his/her partner use) two forms of effective birth control methods starting from 1 month prior to screening and until 3 months following the last BST-236 administration day (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, partner's vasectomy, or double-barrier method condom or diaphragm with spermicide)
  • Patient must voluntarily sign and date an ICF, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
  • Patient must be able to adhere to the study visit schedule and other protocol requirements

Who cannot join

  • Patient has relapsed or refractory AML
  • Patient has acute promyelocytic leukemia
  • Any previous treatment for AML (except for hydroxyurea or up to one treatment course with hypomethylating agents (HMA))
  • Patient has history of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation
  • Previous use (prior to study initiation) of drugs containing cytarabine as an active ingredient
  • Use of any HMA for the treatment of MDS within 30 days of study Day 1
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  • Participation in a previous clinical trial and/or use of an investigational drug within 90 days or at least 5 half-lives of tested drug (whichever is longer) of initial screening assessment
  • Peripheral White Blood Cell (WBC) count >30,000 /µL in the 48 hours prior to first BST-236 dose administration. Hydroxyurea administration or leukapheresis is permitted to meet this criterion
  • Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
  • Any medical or surgical condition, presence of laboratory abnormalities or psychiatric illness that may preclude safe and complete study participation based on the Investigator's judgment
  • Diagnosis of malignant disease within the previous 12 months (excluding basal cell carcinoma of the skin without complications, "in-situ" carcinoma, or other local malignancy excised or irradiated with a high probability of cure and not treated with chemotherapy)
  • Active malignant disease other than AML
  • Leptomeningeal/central nervous system involvement of AML
  • Myeloid sarcoma as a sole manifestation of AML
  • Surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) in the 14 days prior to BST-236 administration
  • Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 4 congestive heart failure
  • Shortness of breath requiring continuous oxygen treatment for at least 15 hours per day in chronically hypoxemic patients
  • History of allergic reactions attributed to compounds of similar chemical composition as BST-236 and/or cytarabine
  • Life expectancy shorter than 3 months attributed to any known medical condition other than AML
  • Active/chronic Hepatitis B Virus (HBV) infection (based on positive surface antigen (HBsAg)), Hepatitis C Virus (HCV) infection (HCV) (based on positive HCV antibody (Ab)), or Human Immunodeficiency Virus (HIV)-1 or HIV-2 (based on positive HIV antibody)

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States11 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

    Columbus, Ohio, 43210

  • Baylor Scott & White Research Institute Dallas Texas

    Dallas, Texas, 75246

  • Franciscan Physician Network Oncology and Hematology Specialists

    Indianapolis, Indiana, 46237

  • West Virginia University

    Morgantown, West Virginia, 26506-9162

  • Memorial Sloan Kettering Cancer Center New York

    New York, New York, 10065

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-4433

Other trials in United States

Israel5 sites

  • Soroka University Medical Center

    Beersheba, PO Box 151

  • Rambam medical center hematology department

    Haifa, 4655202

  • Shaare Zedek Medical Center

    Jerusalem, P.O.B 3235

  • Rabin Medical Center

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

About this study

Official title: A Phase 2b Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults With Newly-Diagnosed Acute Myeloid Leukemia (AML), Not Eligible for Standard Induction Therapy

The purpose of this study is to assesses the benefit, safety, and pharmacokinetics (PK) of BST-236 in patients with newly-diagnosed Acute Myeloid Leukemia (AML) who are not eligible for standard induction chemotherapy due to advanced age or comorbidities. The Complete Remission (CR) rate following treatment with BST-236 will be compared to the CR rate reported in historical data in a similar population.

Read the detailed description

BST-236 is a cytarabine pro drug designed to release cytarabine inside the target cells with reduced systemic exposure to free cytarabine. As such, BST-236 may enable delivery of high doses of cytarabine to medically-unfit or older adults who otherwise cannot be treated with standard cytarabine therapy. This study aims to validate this hypothesis.

The study is an open-label, single arm, single agent, multi-center study in adults with newly diagnosed AML who are unfit for standard therapy. The patients will receive up to 4 courses of six-days treatment with intravenous BST-236; 1 or 2 induction courses followed by 1 to 2 consolidation courses. The study participation will be 52 weeks including treatment and follow-up periods. An additional 1 year post study follow-up for the evaluation of survival is optional.

Being tested
BST-236
Keywords
Acute Myeloid Leukemia, Unfit for standard induction therapy, Cytarabine
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.

  • BST-236Drug

    1 to 4 courses

Study groups in NCT03435848
Study groupRoleWhat they receive
BST-236ExperimentalBST-236 Intravenous, 4.5 g/m2/d or 2.5 g/m2/d, for 6 days
Receives: Drug: BST-236

What is being measured

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

  1. Complete Remission

    as BM blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC >1.0x 109/L (1,000/μL); platelet count >100 x 109/L (100,000/μL)

    Measured: Day 28-35 of induction/re induction course

Timeline

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

  1. First posted19 Feb 2018
  2. Study start14 Aug 2018
  3. Primary completion16 Mar 2023
  4. Study completion16 Mar 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03435848
Sponsor's protocol ID
BST002
Acronym
ELPIS
Status last verified
Jul 2023
First submitted
12 Feb 2018
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Altman JK, Zuckerman T, Koprivnikar J, McCloskey J, Kota V, Keng M, Frankfurt O, Abaza Y, Bixby DL, Emadi A, Burch M, Bhatnagar B, Luger SM, Percival ME, Wolach O, Craig M, Ganzel C, Roboz G, Levi I, Gourevitch A, Flaishon L, Tessler S, Blumberg C, Gengrinovitch S, Ben Yakar R, Rowe JM. Aspacytarabine for the treatment of patients with AML unfit for intensive chemotherapy: a phase 2 study. Blood Adv. 2023 Dec 26;7(24):7494-7500. doi: 10.1182/bloodadvances.2023010943.

    PubMed 37903324

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BST-236 in people with Acute Myeloid Leukemia, run by BioSight Ltd. at 16 sites in 2 countries.

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 21 inclusion and 20 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Israel. 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 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?

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?

Complete Remission (time frame: Day 28-35 of induction/re induction course). 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 NCT03435848, 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 27 Jul 2023.

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