Acute Myeloid LeukemiaPhase 2NCT04069208
IA14 Induction in Young Acute Myeloid Leukemia
A Phase 2 study testing Idarubicin and cytarabine induction in people with Acute Myeloid Leukemia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) is a clinically and biologically heterogeneous disease characterized by the clonal expansion of undifferentiated myeloid precursors. Although induction chemotherapy with cytarabine and daunorubicin/Idarubicin, typically called "7+3", has not changed for several decades, the best dosage of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Idarubicin and cytarabine induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2019to 31 Dec 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening)
- Must be competent and able to comprehend, sign, and date an Ethics Committee or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
- ≥18 yearsand ≤60 years (at Screening);
- Eastern Cooperative Oncology Group performance status 0-2 (at Screening);
- Adequate renal function defined as: Creatinine clearance rate >50 mL/min, as calculated with the modified Cockcroft Gault equation;
- Adequate hepatic function defined as: Total serum bilirubin ≤1.5 × ULN; and serum alkaline phosphatase, aspartate transaminase and alanine transaminase ≤2.5 × ULN;
- Serum electrolytes within normal limits: potassium, calcium (total or corrected for serum albumin in case of hypoalbuminemia). If outside of normal limits, subject will be eligible when electrolytes are corrected;
Who cannot join
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12); subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
- Prior treatment for AML, except for the following allowances:
- Leukapheresis;
- Treatment for hyperleukocytosis with hydroxyurea;
- Growth factor/cytokine support;
- Uncontrolled or significant cardiovascular disease, including any of the following:
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- Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
- Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
- History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
- History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
- History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
- History of New York Heart Association Class 3 or 4 heart failure;
- Complete left bundle branch block;
- Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
- Concurrent of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
- Females who are pregnant or breastfeeding;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinxin Cao
Beijing, Beijing Municipality, 100038
Xinxin Cao, caoxinxin@pumch.cn
About this study
Official title: Dose-intense Idarubicin Induction in Young Patients With Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a clinically and biologically heterogeneous disease characterized by the clonal expansion of undifferentiated myeloid precursors. Although induction chemotherapy with cytarabine and daunorubicin/Idarubicin, typically called "7+3", has not changed for several decades, the best dosage of anthracycline is still unknown. Several prospective trials have demonstrated that intense dosage of anthracycline improved complete remission (CR) and overall survival (OS). Idarubicin 12mg/m2 (IA12) has been shown to be equal to dose intense daunorubicin (90 mg/m2 ) for achieving CR. Dose-intense daunorubicin 90 mg/m2 (DA90) has been shown to improve CR compared to standard dose daunorubucin 45mg/m2 in newly diagnosed AML patients. In our previous study, CR rate of induction with daunorubicin 60 mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 was about 67%. Benefit of intensification seems limited to the patients without adverse cytogenetics. Wheher ultra high dose idarubicin 14mg/m2 (IA14) could further improve CR rate, give patients with adverse cytogenetics a chance to do allo-stem cell transplantation? This phase 2, prospective, single-center study is designed to evaluate the efficacy and safety of induction with idarubicin 14mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 in young newly diagnosed AML patients.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Idarubicin and cytarabine induction
- Keywords
- Acute Myeloid Leukemia, ultra-high dose idarubicin, induction
- 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.
Idarubicin and cytarabine inductionDrug
Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days
| Study group | Role | What they receive |
|---|---|---|
| IA14 | Experimental | Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days Receives: Drug: Idarubicin and cytarabine induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate
the rate of patient who get CR after induction therapy
Measured: On Day 21 (window Day 21 to Day 30), a bone marrow aspirate specimen will be collected for pathology.
Secondary outcomes (3)
Event-free survival (EFS)
EFS is defined as the duration from initiation of IA induction treatment to the date of a first event
Measured: Assessed up to 24 months. Event is defined as any of the following: 1)Refractory disease (or treatment failure) which is determined at the end of the Induction Phase; 2)Relapse after CR or CRi; 3)Death from any cause at any time during the study.
Overall survival (OS)
OS was defined as the duration from initiation of IA induction treatment to the date of death or last follow-up
Measured: OS was defined as the duration from initiation of IA induction treatment to the date of death or last follow-up assessed up to 24 months.
rate of Minimal Residual Disease (MRD) negativity
Percentage of subjects achieving CR with no evidence of Minimal Residual Disease (MRD) following induction therapy.
Measured: MRD will be tested after on Day 21 (window Day 21 to Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start3 Sep 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao Xinxin, Peking Union Medical College Hospital
- Investigators
- Jian Li, M.D., Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069208
- Sponsor's protocol ID
- AML-IA14
- Status last verified
- Jun 2021
- First submitted
- 22 Aug 2019
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-intense Idarubicin Induction in Young Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04069208
- Acronym / sponsor ID
- AML-IA14
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, ultra-high dose idarubicin, induction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myeloid leukemia (AML) is a clinically and biologically heterogeneous disease characterized by the clonal expansion of undifferentiated myeloid precursors. Although induction chemotherapy with cytarabine and daunorubicin/Idarubicin, typically called "7+3", has not changed for several decades, the best dosage of anthracycline is still unknown. Several prospective trials have demonstrated that intense dosage of anthracycline improved complete remission (CR) and overall survival (OS). Idarubicin 12mg/m2 (IA12) has been shown to be equal to dose intense daunorubicin (90 mg/m2 ) for achieving CR. Dose-intense daunorubicin 90 mg/m2 (DA90) has been shown to improve CR compared to standard dose daunorubucin 45mg/m2 in newly diagnosed AML patients. In our previous study, CR rate of induction with daunorubicin 60 mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 was about 67%. Benefit of intensification seems limited to the patients without adverse cytogenetics. Wheher ultra high dose idarubicin 14mg/m2 (IA14) could further improve CR rate, give patients with adverse cytogenetics a chance to do allo-stem cell transplantation? This phase 2, prospective, single-center study is designed to evaluate the efficacy and safety of induction with idarubicin 14mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 in young newly diagnosed AML patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days
| Arm | Type | Receives |
|---|---|---|
| IA14 | Experimental | Drug: Idarubicin and cytarabine inductionIdarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening)
- Must be competent and able to comprehend, sign, and date an Ethics Committee or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
- ≥18 yearsand ≤60 years (at Screening);
- Eastern Cooperative Oncology Group performance status 0-2 (at Screening);
- Adequate renal function defined as: Creatinine clearance rate >50 mL/min, as calculated with the modified Cockcroft Gault equation;
Key exclusion criteria (18 listed)
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12); subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
- Prior treatment for AML, except for the following allowances:
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
- Concurrent of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idarubicin and cytarabine inductionIdarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days | Drug | IA14 |
Primary outcome
Complete remission (CR) rate
Time frame: On Day 21 (window Day 21 to Day 30), a bone marrow aspirate specimen will be collected for pathology.
the rate of patient who get CR after induction therapy
3 secondary outcomes
Event-free survival (EFS)
Time frame: Assessed up to 24 months. Event is defined as any of the following: 1)Refractory disease (or treatment failure) which is determined at the end of the Induction Phase; 2)Relapse after CR or CRi; 3)Death from any cause at any time during the study.
Overall survival (OS)
Time frame: OS was defined as the duration from initiation of IA induction treatment to the date of death or last follow-up assessed up to 24 months.
rate of Minimal Residual Disease (MRD) negativity
Time frame: MRD will be tested after on Day 21 (window Day 21 to Day 30)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Li, M.D. study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Idarubicin and cytarabine induction in people with Acute Myeloid Leukemia, run by Peking Union Medical College Hospital 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 7 inclusion and 18 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 Jun 2021. 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 Xinxin Cao (69155027, caoxinxin@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) rate (time frame: On Day 21 (window Day 21 to Day 30), a bone marrow aspirate specimen will be collected for pathology.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2021.