Acute Myeloid LeukemiaPhase 3NCT01484171
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
A Phase 3 study testing idarubicin and microtransplantation in people with Acute Myeloid Leukemia, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 7 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- idarubicin and microtransplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Dec 2017
- Phase
- Phase 3
- 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 7 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having signed informed consent
- Diagnosis was based on the French-American-British (FAB) and WHO criteria.
- Age ≥ 7 years old
- Age < 60 years old
Who cannot join
- 1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of the Chinese Academy of Military Medical Science
Beijing, Beijing Municipality, 100071
huisheng ai, M.D., 86-01-66947126, huishengai@163.com
zheng dong, M.M, 86-01-66947130, dongz1983@139.com
About this study
To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- idarubicin, microtransplantation
- Keywords
- Acute Myeloid Leukemia, idarubicin, Microtransplantation
- 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 10-12 mg/m2 for three days
microtransplantationBiological
idarubicin 10-12mg/m2 for four days. After chemotherapy infusion granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells following each of three cycles of high dose cytarabine chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| idarubicin | Active comparator | The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine. Receives: Drug: idarubicin |
| microtransplantation | Experimental | The patients will receive induction chemotherapy containing high dose of idarubicin in combination with cytarabine and follow by infusioning granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells Receives: Biological: microtransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission
Measured: one year
Secondary outcomes (2)
disease-free survival
Measured: three years
overall survival
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huisheng ai, M.D., Principal investigator, The Affiliated Hospital of the Chinese Academy of Military Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484171
- Sponsor's protocol ID
- MST-AML-307PLAH-ASH
- Status last verified
- Jul 2016
- First submitted
- 1 Dec 2011
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01484171
- Acronym / sponsor ID
- MST-AML-307PLAH-ASH
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, idarubicin, Microtransplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Dec 2011 (estimated)
- 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.
To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| idarubicin | Active comparator | Drug: idarubicinThe patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine. |
| microtransplantation | Experimental | Biological: microtransplantationThe patients will receive induction chemotherapy containing high dose of idarubicin in combination with cytarabine and follow by infusioning granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Having signed informed consent
- Diagnosis was based on the French-American-British (FAB) and WHO criteria.
- Age ≥ 7 years old
- Age < 60 years old
Key exclusion criteria (1 listed)
- 1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia
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 |
|---|---|---|
| idarubicinidarubicin 10-12 mg/m2 for three days | Drug | idarubicin |
| microtransplantationidarubicin 10-12mg/m2 for four days. After chemotherapy infusion granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells following each of three cycles of high dose cytarabine chemotherapy | Biological | microtransplantation |
Primary outcome
complete remission
Time frame: one year
2 secondary outcomes
disease-free survival
Time frame: three years
overall survival
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
huisheng ai, M.D. principal investigator
The Affiliated Hospital of the Chinese Academy of Military Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing idarubicin and microtransplantation in people with Acute Myeloid Leukemia, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences 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 4 inclusion and 1 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 13 Jul 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 huisheng ai, Doctor of Medicine (86-01-66947126, huishengai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission (time frame: one year). 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 13 Jul 2016.