Acute Myeloid LeukemiaNCT02676856
Hematopoietic Stem Cell Microtransplantation for in AML
A study testing hematopoietic stem cell microtransplantation-long-term, hematopoietic stem cell microtransplantation-short-term and Conditioning for CR group in people with Acute Myeloid Leukemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- hematopoietic stem cell microtransplantation-long-term, hematopoietic stem cell microtransplantation-short-term and Conditioning for CR group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Aug 2018
- Phase
- Interventional
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy
- Intolerance or unwillingness of allogeneic HSCT
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Fen Huang, +86-020-62787883, 13826204917@163.com
About this study
Official title: Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia
The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).
Read the detailed description
Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- hematopoietic stem cell microtransplantation-long-term, hematopoietic stem cell microtransplantation-short-term, Conditioning for CR group, Conditioning for Non-CR group
- Keywords
- acute myeloid leukemia, hematopoietic stem cell 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.
hematopoietic stem cell microtransplantation-long-termProcedure or surgery
Stem cell infusion are administrated once three months for 3 times with the cell count of 3*10^8/kg/once.
hematopoietic stem cell microtransplantation-short-termProcedure or surgery
Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3*10^8/kg/once.
Conditioning for CR groupDrug
For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
Conditioning for Non-CR groupDrug
For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).
| Study group | Role | What they receive |
|---|---|---|
| CR group | Experimental | For the patients in CR group(CR status of AML at microtransplantation), the conditioning regimen is high-dose (HD) Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with long-term course. Receives: Procedure: hematopoietic stem cell microtransplantation-long-term; Drug: Conditioning for CR group |
| Non-CR group | Experimental | For the patients in Non-CR group (PR or NR status of AML at microtransplantation), the conditioning regimens include: IAC or HD Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with short-term course. Receives: Procedure: hematopoietic stem cell microtransplantation-short-term; Drug: Conditioning for Non-CR group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation
Measured: 2 years
relapse rate
Measured: 2 years
Secondary outcomes (3)
Overall Survival
Measured: 2 years
Disease-free Survival
Measured: 2 years
Incidence of chimerism
Incidence of chimerism will be evaluated in the patients. Both peripheral-blood cells and bone marrow are tested for hematopoietic donor chimerism by a standard cytogenetic analysis and a semiquantitative PCR-based analysis of the short tandem repeats.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676856
- Sponsor's protocol ID
- Microtransplantation-AML-2016
- Status last verified
- Feb 2016
- First submitted
- 31 Jan 2016
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kong X, Chen Y, Wang LI, Zhou Y, He Y, Nie W, Zhang X, Yin X. Effect of the microtransplantation of allogeneic hematopoietic stem cells as maintenance therapy for elderly patients with acute leukemia. Oncol Lett. 2015 May;9(5):2331-2334. doi: 10.3892/ol.2015.2995. Epub 2015 Feb 27.
PubMed 26137066
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02676856
- Acronym / sponsor ID
- Microtransplantation-AML-2016
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, hematopoietic stem cell microtransplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 8 Feb 2016 (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.
The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).
Detailed description
Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CR group | Experimental | Procedure: hematopoietic stem cell microtransplantation-long-term, Drug: Conditioning for CR groupFor the patients in CR group(CR status of AML at microtransplantation), the conditioning regimen is high-dose (HD) Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with long-term course. |
| Non-CR group | Experimental | Procedure: hematopoietic stem cell microtransplantation-short-term, Drug: Conditioning for Non-CR groupFor the patients in Non-CR group (PR or NR status of AML at microtransplantation), the conditioning regimens include: IAC or HD Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with short-term course. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy
- Intolerance or unwillingness of allogeneic HSCT
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Key exclusion criteria (2 listed)
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
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 cell microtransplantation-long-termStem cell infusion are administrated once three months for 3 times with the cell count of 3*10^8/kg/once. | Procedure or surgery | CR group |
| hematopoietic stem cell microtransplantation-short-termStem cell infusion are administrated once every 45 days for 3 times with the cell count of 3*10^8/kg/once. | Procedure or surgery | Non-CR group |
| Conditioning for CR groupFor the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3). | Drug | CR group |
| Conditioning for Non-CR groupFor the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3). | Drug | Non-CR group |
Primary outcome
CR rate
Time frame: 2 years
The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation
relapse rate
Time frame: 2 years
3 secondary outcomes
Overall Survival
Time frame: 2 years
Disease-free Survival
Time frame: 2 years
Incidence of chimerism
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Background: PubMed 26137066Kong X, Chen Y, Wang LI, Zhou Y, He Y, Nie W, Zhang X, Yin X. Effect of the microtransplantation of allogeneic hematopoietic stem cells as maintenance therapy for elderly patients with acute leukemia. Oncol Lett. 2015 May;9(5):2331-2334. doi: 10.3892/ol.2015.2995. Epub 2015 Feb 27.
- Individual participant dataSharing planned: No
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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.
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hematopoietic stem cell microtransplantation-long-term, hematopoietic stem cell microtransplantation-short-term and Conditioning for CR group in people with Acute Myeloid Leukemia, run by Nanfang Hospital, Southern Medical University 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 8 Dec 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.
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 Fen Huang (+86-020-62787883, 13826204917@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02676856, 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 Dec 2017.