AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2NCT02937662

Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML

A Phase 2 study testing Idarubicin, Cytarabine and Cyclophosphamide in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. Read more about this study

Who is it for?
Ages 0 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Idarubicin, Cytarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Oct 2016to 30 Apr 2020
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 0 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age of less than 60 years old;
  • Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
  • Patients with a confirmed pathologic diagnosis of AML which had relapsed or refractory.
  • Patients with ECOG score of ≤ 2;
  • Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Who cannot join

  • Patients who had received reinduction therapy including cyclophosphamide are excluded. However, patients who had received regimens including cyclophosphamide before relapse are eligible.
  • Patients with other blood diseases(for example, haemophiliacs) are excluded.
  • Relapsed patients with only extramedullary leukemia;
  • After allogeneic hematopoietic stem cell transplantation;
  • With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
  • Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
Show all 9Show fewer
  • Had other malignant tumor in need of treatment;
  • Had active cardiovascular disease;
  • Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin

Other trials in China

About this study

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. The primary end point is complete remission rate.

Read the detailed description

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. Patients in the IAC arm receive the therapy consisting of idarubicin 10 mg/㎡/d on days 1-3, cytarabine 100mg/㎡/d on days 1-7 and cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day. In the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(FLA±G) regimen,cytarabine plus daunorubicin(DA）regimen , decitabine,aclacinomycin and cytarabine(decitabine plus AA) regimen or AA regimen plus granulocyte stimulating factor. All the regimen in the control arm can not contain cyclophosphamide. The primary end point is complete remission. The second end points include overall survival, relapse-free survival and time to treatment failure.

Being tested
Idarubicin, Cytarabine, Cyclophosphamide, Physician-Directed Regimens without Cyclophosphamide
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.

  • IdarubicinDrug

    Idarubicin at a dose of 10 mg/㎡/d on days 1-3.

  • CytarabineDrug

    Also called Ara-c

    Cytarabine at a dose of 100mg/㎡/d on days 1-7.

  • CyclophosphamideDrug

    Also called CTX

    Cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day.

  • Physician-Directed Regimens without CyclophosphamideDrug

    Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.

Study groups in NCT02937662
Study groupRoleWhat they receive
IAC regimenExperimentalPatients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.
Receives: Drug: Idarubicin; Drug: Cytarabine; Drug: Cyclophosphamide
Control GroupActive comparatorPatients receive physician-directed regimens without cyclophosphamide including FLA±G regimen, AAG regimen, decitabine with AA regimen. Physicians can choose one of these regimens based on their experience and patients' condition.
Receives: Drug: Physician-Directed Regimens without Cyclophosphamide

What is being measured

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

  1. Complete Remission Rate

    Measured: Within 6 weeks after induction therapy

Secondary outcomes (3)

  1. Overall Survival(OS)

    OS is defined as the time from the date of randomization until the date of death from any cause.

    Measured: Up to 3 years

  2. Relapse-Free Survival(RFS)

    RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for subjects who achieve CR.

    Measured: Up to 3 years

  3. Time to Treatment Failure(TTF)

    TTF is defined as the time from the date of randomization until the date of death before response evaluation, not achieving CR or incomplete remission(CRi), or relapse/death after CR/CRi.

    Measured: Up to 3 years

Timeline

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

  1. First posted18 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02937662
Sponsor's protocol ID
IIT2016006
Status last verified
Mar 2019
First submitted
17 Oct 2016
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Idarubicin, Cytarabine and Cyclophosphamide in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 inclusion and 9 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 30 May 2025. 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?

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 Rate (time frame: Within 6 weeks after induction therapy). 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 NCT02937662.

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 30 May 2025.

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