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AzTrials

Acute Myeloid LeukemiaPhase 2NCT03338348

Study of Vosaroxin With Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2

A Phase 2 study testing Vosaroxin and Azacitidine in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2), run by University of Ulm at 3 sites in Germany.

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 main part of this trial is a phase II study of vosaroxin with azacitidine in older patients with newly diagnosed AML and intermediate or adverse genetic risk or MDS-EB-2. An initial safety run-in phase of the study will be performed administering the study drug vosaroxin with azacitidine in up to 18 patients. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Vosaroxin and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
3 sitesGermany
Study dates
19 Apr 2018to 31 Oct 2019
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with confirmed diagnosis of acute myeloid leukemia (WHO 2016) and intermediate or adverse genetic risk (according to 2017 ELN recommendations); or patients with myelodysplastic syndrome with excess blasts-2 (MDS-EB-2)
  • Patients ≥60 years of age
  • No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis for up to 10 days during the diagnostic screening phase; patients may have received prior therapy for myelodysplastic syndrome different from hypomethylating agents
  • ECOG performance status ≤2
  • Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 3 month after the last dose of vosaroxin)
  • Non-pregnant and non-nursing women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months).
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  • Female patients of reproductive age must agree to avoid getting pregnant while on therapy and for 3 months after the last dose of vosaroxin.
  • Women of child-bearing potential including the female partners of the male patients must either commit to continued abstinence from heterosexual intercourse or apply two acceptable methods of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control.
  • Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy (while on therapy and for three months after the last dose of chemotherapy)
  • Willing to adhere to protocol specific requirements
  • Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

Who cannot join

  • Known or suspected hypersensitivity to the study drugs and/or any excipients
  • Favorable genetics: t(15;17)(q22;q12), PML-RARA; t(8;21)(q22;q22), RUNX1-RUNX1T1; inv(16)(p13.1q22)/t(16;16)(p13.1;q22), CBFB-MYH11; mutated NPM1 without FLT3-ITD or with FLT3-ITDlow
  • Prior treatment for AML except hydroxyurea
  • Prior treatment for MDS with hypomethylating agents
  • ECOG performance status >2
  • Patients who are not eligible for intensive chemotherapy
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  • Inadequate cardiac, hepatic and/or renal function at the Screening Visit defined as:
  • Ejection fraction <40% confirmed by echocardiography
  • Creatinine >1.5x upper normal serum level
  • Total bilirubin, AST or ALT >1.5 upper normal serum level
  • Active central nervous system involvement
  • Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations or put the patient at special risk, such as:
  • Myocardial infarction, unstable angina within 3 months before screening
  • Heart failure NYHA III/IV
  • Severe obstructive or restrictive ventilation disorder
  • Uncontrolled infection
  • Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
  • Currently receiving a therapy not permitted during the study, as defined in Section 10.5.4
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
  • Known history of positive test for Hepatitis B surface Antigen (HBsAg) or hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
  • Hematological disorder independent of leukemia
  • No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation
  • No consent for biobanking
  • Current participation in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the study
  • Patients known or suspected of not being able to comply with this trial protocol
  • Patients of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of therapy
  • Breast feeding women or women with a positive pregnancy test at Screening visit

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Kliniken Essen-Süd, Evang. Krankenhaus Essen-Werden gGmbH

    Essen, 45239

  • Klinikum Oldenburg, Klinik für Innere Medizin II

    Oldenburg, 26133

  • University Hospital Ulm

    Ulm, 89081

Other trials in Germany

About this study

Official title: A Phase II Study With a Safety Run-in Phase Evaluating Vosaroxin With Azacitidine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia and Intermediate/Adverse Genetic Risk or Myelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2) - AMLSG 24-15

The main part of this trial is a phase II study of vosaroxin with azacitidine in older patients with newly diagnosed AML and intermediate or adverse genetic risk or MDS-EB-2. An initial safety run-in phase of the study will be performed administering the study drug vosaroxin with azacitidine in up to 18 patients. After completion of the run-in phase, toxicity and response data will be provided to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the Coordinating Investigator. The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the vosaroxin dose for the phase II part of the study, which will include 150 patients in total.

Being tested
Vosaroxin, Azacitidine
Keywords
Vosaroxin
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.

  • VosaroxinDrug

    Cycle 1-8: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 .

  • AzacitidineDrug

    Cycle 1-8 Azacitidine: 75 mg/m²/d subcutaneously, d 1-7;

    Maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression.

Study groups in NCT03338348
Study groupRoleWhat they receive
Azacitidine + VosaroxinOtherCycle 1-8: Azacitidine: 75 mg/m²/d subcutaneously, d 1-7; Vosaroxin: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 . Patients who have completed 8 cycles of azacitidine and vosaroxin are scheduled to maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression.
Receives: Drug: Vosaroxin; Drug: Azacitidine

What is being measured

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

  1. Rate of complete remission (CR) and CR with incomplete blood count recovery (CRi)

    Efficacy assessments

    Measured: 2 months

Secondary outcomes (8)

  1. CR and CRi in a pre-defined subgroup analysis in patients with complex karyotype

    Efficacy assessments

    Measured: 2 months

  2. CR and rate of combined CR/CRi and CR with negativity for minimal residual disease (CRMRD-)

    Efficacy assessments

    Measured: 2 months

  3. Duration of response (DOR)

    Efficacy assessments

    Measured: 4 years

  4. Event-free survival (EFS)

    Efficacy assessments

    Measured: 4 years

  5. Overall survival (OS)

    Efficacy assessments

    Measured: 4 years

  6. 30-day and 60-day mortality

    Safety assessments

    Measured: 30 and 60 days

  7. Incidence and intensity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version v4.0

    Safety assessments

    Measured: 12 months

  8. Assessment of Quality of life by the EORTC Quality of Life Core Questionnaire (QLQ-C30)

    Quality of life

    Measured: 4 years

Timeline

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

  1. First posted9 Nov 2017
  2. Study start19 Apr 2018
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03338348
Sponsor's protocol ID
AMLSG 24-15
Status last verified
Oct 2020
First submitted
2 Nov 2017
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vosaroxin and Azacitidine in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2), run by University of Ulm at 3 sites in Germany.

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 11 inclusion and 27 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 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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?

Rate of complete remission (CR) and CR with incomplete blood count recovery (CRi) (time frame: 2 months). 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 NCT03338348.

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 28 Oct 2020.

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