Leukemia, MyeloidPhase 1/2NCT03080922
High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML
A Phase 1/2 study testing hematopoietic stem cell in people with Leukemia, Myeloid, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Leukemia, Myeloid
- What is being tested?
- hematopoietic stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2019
- Phase
- Phase 1/2
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with relapsed and/or refractory AML
- Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Who cannot join
- Previous treatment with investigational gene or cell therapy medicine products
- Any uncontrolled active medical disorder that would preclude participation as outlined
Trial locations and contacts
1 site in 1 country.
HUISHENG AI contact
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Academy of Military Medical Sciences ,
Beijing, Beijing Municipality, 100071
Huisheng Ai, MD, 86-1066947126, huishengai@163.com
Huisheng Ai, MD
About this study
Official title: Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy
The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.
Read the detailed description
The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.
no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.
- Conditions
- Leukemia, Myeloid
- Being tested
- hematopoietic stem cell
- Keywords
- Acute Myeloid Leukemia, Relapsed, Refractory, hematopoietic stem cell
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hematopoietic stem cellBiological
high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| hematopoietic stem cell | Experimental | high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy Receives: Biological: hematopoietic stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
Measured: 2 months
Secondary outcomes (4)
Disease-free survival
Measured: 2 years
Overall survival
Measured: 2 years
donor graft rate
Measured: 6 months
Occurrence of study related adverse events
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, MyeloidStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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, Study chair, Affiliated Hospital of Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080922
- Sponsor's protocol ID
- HD-DSI-AML
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy
- ClinicalTrials.gov ID
- NCT03080922
- Acronym / sponsor ID
- HD-DSI-AML
- Conditions
- Leukemia, Myeloid
- Keywords
- Acute Myeloid Leukemia, Relapsed, Refractory, hematopoietic stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 15 Mar 2017 (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.
The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.
Detailed description
The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.
no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hematopoietic stem cell | Experimental | Biological: hematopoietic stem cellhigh dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with relapsed and/or refractory AML
- Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (2 listed)
- Previous treatment with investigational gene or cell therapy medicine products
- Any uncontrolled active medical disorder that would preclude participation as outlined
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 |
|---|---|---|
| hematopoietic stem cellhigh dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy | Biological | hematopoietic stem cell |
Primary outcome
complete remission rate
Time frame: 2 months
4 secondary outcomes
Disease-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
donor graft rate
Time frame: 6 months
Occurrence of study related adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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 contact
HUISHENG AI study chair
Affiliated Hospital of Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hematopoietic stem cell in people with Leukemia, Myeloid, 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 3 inclusion and 2 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 4 Apr 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 HUISHENG AI (HUISHNGAI@163.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: 2 months). 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 4 Apr 2017.