AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2NCT04248595

Study of Azacitidine Combined With Homoharringtonie Based Regimens in AML

A Phase 2 study testing Homoharringtonine and Azacitidine in people with Acute Myeloid Leukemia, run by Ge Zheng at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Rencent years have witnessed great progress of the treatment of acute myeloid leukemia (AML). However, most patients have poor outcomes following the currently first-line DA(daunorubicin, cytarabine)/IA(Idarubicin, cytarabine) chemotherapy, espiecially for the older patients and those not eligiable for receiving… Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Homoharringtonine and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Dec 2019to 30 Dec 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnoised with acute myeloid leukemia
  • Meet the criteria of the 2016 WHO classification system(APL were excluded), based on blood cell counting, bone marrow biopsy, and cytogeneic diagnosis
  • Volunteered to sign the informed consent.

Who cannot join

  • Mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring
  • Uncontrolled cardiovascular disease
  • Allergic to azacytarine, homoharringtonie, or other drugs of this study
  • Any other conditions considered by the study investgators that are not suitable for participating in this clinical trial.

Trial locations and contacts

1 site in 1 country.

Zheng Ge, M.D, Ph.D contact

02583262468 ext. 02583262468

Janege879@hotmail.com

China1 site, 1 recruiting

  • Department of Hematology, Zhongda Hospital, Medical School of Southeast University

    Nanjing, 210000

    Zheng o Ge, MD,PhD, 02583262468 ext. 02583262468, Janege879@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Azacitidine Combined With Homoharringtonie Based Regimens in Acute Myeloid Leukemia

Rencent years have witnessed great progress of the treatment of acute myeloid leukemia (AML). However, most patients have poor outcomes following the currently first-line DA(daunorubicin, cytarabine)/IA(Idarubicin, cytarabine) chemotherapy, espiecially for the older patients and those not eligiable for receiving allo-HSCT. Azacitidine (AZA)，a hypomethylating agent, targets epigenetic gene silencing by inhibiting gene expression against malignant phenotypes and is currently approved to treat AML based on the NCCN guidelines. The homoharringtonie (HHT) could induce AML cell lines and primary myeloid leukemia cell apoptosis, and the effect was dose dependent. While, HHT could also induce leukemia cells to differentiate into normal state, eventually achieve the goal of treatment, and control the disease. The investigators conducted a clinical study to evaluate the efficacy and safety of the AZA plus HAG(homoharringtonie, cytarabine, G-CSF), HIA(homoharringtonie, Idarubicin, cytarabine)/HDA(homoharringtonie, daunorubicin, cytarabine). This study is aimed to demonstrate the efficacy and safety advantages of the regimens that cotain homoharringtonie and azacitidine.

Read the detailed description

Currently, the treatment of acute myeloid leukemia (AML) still remains a therapeutic challenge. Patients received traditional chemotherapy have a low remission rate, poor prognosis and short survival for patients. New treatment strategies are needed in find out a better chemotherapy regimen.

Azacitidine (AZA), a hypomethylating agent, targets epigenetic gene silencing by inhibiting gene expression against malignant phenotypes. Azacitidine is currently approved to treat AML based on the NCCN guidelines. Novel combinations based on the azacitidine are currently undergoing, and the preliminary results brought promising hope to the treatment of AML.

The homoharringtonie (HHT) is a plant cytotoxic alkaloid derived from the trees of the genus Cephalotaxus. As a protein synthesis inhibitor, homoharringtonie plays a major role in the G1 / G2 phase in cells. In addition, it could induce AML cell lines and primary myeloid leukemia cell apoptosis, and the effect was dose dependent. Meanwhile it could also induce leukemia cells to differentiate into normal state, eventually controlled the progression of the disease.

Combination with azacitidine may become a new option.This study intends to apply azacitidine in combination with homoharringtonie for treating AML patients, aiming to improve the efficacy, reduce adverse events and improve the living qualities of patients.

Patients of de novo or relapsed AML(age≥60y or ineligibility to receive intensive chemotherapy) will receive AZA+HAG (homoharringtonie, cytarabine, G-CSF) regiment as induction therapy. After complete remission(CR), the AZA+HAG regimen was further given 4-6 cycles and followed by azacitidine maintenance or until the disease progresses.

Patients of de novo or relapsed AML(age<60y or eligible for intensive chemotherapy) will receive AZA +HIA(homoharringtonie, Idarubicin, cytarabine) or AZA+HDA(homoharringtonie, daunorubicin, cytarabine) regiments as introduction therapy. After CR, post-remission therapy will follow with NCCN guidelines.

The investigators choose historical AML patients receiving tranditional chemotherapy as a control group, to evaluate the efficacy and safety profiles.

Being tested
Homoharringtonine, Azacitidine
Keywords
Acute myeloid leukemia, Homoharringtonie, Azacitidine, Demethylation
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.

  • HomoharringtonineDrug

    Also called HHT, Omacetaxine mepesuccinate

    De novo AML or relapsed AML patients recieve chemotherapy regimen contained homoharringtonie and azacitidine.

  • AzacitidineDrug

    Also called AZA

    De novo AML or relapsed AML patients recieve chemotherapy regimen contained homoharringtonie and azacitidine.

Study groups in NCT04248595
Study groupRoleWhat they receive
Azacitidine plus HAGExperimentalPatients of de novo or relapsed AML(age≥60y or ineligibility to receive intensive chemotherapy) will receive AZA+HAG (homoharringtonie, cytarabine, G-CSF) regiment as induction therapy. After complete remission(CR), the AZA+HAG regimen was further given 4-6 cycles and followed by azacitidine maintenance or until the disease progresses. AZA -Azacitidine HAG -Homoharringtonie, Cytarabine, G-CSF
Receives: Drug: Homoharringtonine; Drug: Azacitidine
Azacitidine plus HIAExperimentalPatients of de novo or relapsed AML(age<60y or eligible for intensive chemotherapy) will receive AZA +HIA(homoharringtonie, Idarubicin, cytarabine) regiments as introduction therapy. After CR, post-remission therapy will follow with NCCN guidelines. AZA -Azacitidine HIA -Homoharringtonie, Cytarabine, Idarubicin
Receives: Drug: Homoharringtonine; Drug: Azacitidine
Azacitidine plus HDAExperimentalPatients of de novo or relapsed AML(age<60y or eligible for intensive chemotherapy) will receive AZA +HDA(homoharringtonie, daunorubicin, cytarabine) regiments as introduction therapy., After CR, post-remission therapy will follow with NCCN guidelines. AZA -Azacitidine HDA -Homoharringtonie, Cytarabine, Daunorubicin
Receives: Drug: Homoharringtonine; Drug: Azacitidine

What is being measured

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

  1. CR

    CR in months, in present of complete remission rate of all participants.

    Measured: From date of randomization or initial treatment until the date of first documented disease relapse from any cause，assessed up to 100 weeks.

Secondary outcomes (3)

  1. Adverse events rates

    Adverse events rates in percetage.

    Measured: From date of randomization or initial treatment until the end date of the study, assessed up to 100 weeks.

  2. RFS

    RFS in months, in present of relapse free survival period of all participants

    Measured: From date of randomization or complete remission until the date of first documented disease relapse from any cause，assessed up to 100weeks.

  3. OS

    OS in months, in present of overall survival period of all participants

    Measured: From date of randomization until the date of first documented death from any cause or end of this study, whichever come first，assessed up to 100weeks.

Timeline

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

  1. First posted30 Jan 2020
  2. Study start1 Dec 2019
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248595
Sponsor's protocol ID
ZDYYGZ201912
Status last verified
Sep 2022
First submitted
22 Jan 2020
Last updated
8 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li J, Huang Y, Hou Y, Gu Y, Song C, Ge Z. High efficacy of azacitidine combined with homoharringtonine, idarubicin, and cytarabine in newly diagnosed patients with AML: A single arm, phase 2 trial. Front Oncol. 2022 Dec 8;12:1069246. doi: 10.3389/fonc.2022.1069246. eCollection 2022.

    PubMed 36568250

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Homoharringtonine and Azacitidine in people with Acute Myeloid Leukemia, run by Ge Zheng at 1 site in China.

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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

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

Contact Zheng Ge, M.D, Ph.D (02583262468 ext. 02583262468, Janege879@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR (time frame: From date of randomization or initial treatment until the date of first documented disease relapse from any cause，assessed up to 100 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 NCT04248595, 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 8 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in