Acute Myeloid LeukemiaPhase 3NCT02059720
Haplo-SCT vs ASCT With or Without Decitabine in AML CR1
A Phase 3 study testing HSCT in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- HSCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18y
- Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time
- Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)
- Presence of an available haplo-mismatch related donor
Who cannot join
- Contra-indications of chemotherapy or hematopoietic stem cell transplantation
- Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor
- Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT
- No effective contraception
- Pregnant or lactating females
- Other causes which are not suitable for the trial in investigator's consideration
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fisrt Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Depei Wu, M.D., Ph.D., +86 512 6778 1856, wudepei@medmail.com.cn
Jia Chen, M.D., +86 512 6778 1856, chenjia@suda.edu.cn
About this study
Official title: Haplo-mismatch Donor Stem Cell Transplantation (SCT) Versus Autologous SCT Followed or Not by Maintenance Therapy, for Patients With Acute Myeloid Leukemia (AML) in First Remission: A Chinese Randomized Multicenter Study
A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- HSCT
- Keywords
- acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, maintenance treatment, hematopoietic stem cell transplantation
- 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.
HSCTProcedure or surgery
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.
| Study group | Role | What they receive |
|---|---|---|
| auto | Active comparator | patients receive autologous SCT Receives: Procedure: HSCT |
| haplo | Active comparator | patients receive haplo-SCT Receives: Procedure: HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukemia-Free Survival
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up.
Measured: Five years
Secondary outcomes (4)
Overall survival
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death or the end of follow-up.
Measured: Five years
Cumulative relapse incidence
Defined as the cumulative incidence of morphological relapse after the day of graft infusion.
Measured: Five years
Non-relapse Mortality
Defined as the cumulative incidence of death without cause of disease recurrence, which include the cause of GVHD, infection, hemorrhage, organic function failure, etc.
Measured: Five years
Cumulative incidence of engraftment
Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (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
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Blood and Marrow Transplantation
- Responsible party
- Sponsor
- Investigators
- Depei Wu, M.D., Ph.D., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059720
- Sponsor's protocol ID
- SZ3702
- Other IDs
- ChiCTR-TRC-14004196
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haplo-mismatch Donor Stem Cell Transplantation (SCT) Versus Autologous SCT Followed or Not by Maintenance Therapy, for Patients With Acute Myeloid Leukemia (AML) in First Remission: A Chinese Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT02059720
- Acronym / sponsor ID
- SZ3702
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, maintenance treatment, hematopoietic stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- European Society for Blood and Marrow Transplantation
- Study start
- Feb 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Feb 2014 (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.
A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| auto | Active comparator | Procedure: HSCTpatients receive autologous SCT |
| haplo | Active comparator | Procedure: HSCTpatients receive haplo-SCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18y
- Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time
- Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)
- Presence of an available haplo-mismatch related donor
Key exclusion criteria (6 listed)
- Contra-indications of chemotherapy or hematopoietic stem cell transplantation
- Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor
- Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT
- No effective contraception
- Pregnant or lactating females
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 |
|---|---|---|
| HSCTPatients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved. | Procedure or surgery | auto, haplo |
Primary outcome
Leukemia-Free Survival
Time frame: Five years
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up.
4 secondary outcomes
Overall survival
Time frame: Five years
Cumulative relapse incidence
Time frame: Five years
Non-relapse Mortality
Time frame: Five years
Cumulative incidence of engraftment
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for Acute Myeloid Leukemia
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
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.
Depei Wu, M.D., Ph.D. principal investigator
The First Affiliated Hospital of Soochow University
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 HSCT in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow 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 4 inclusion and 6 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 5 Feb 2020. 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 Depei Wu, M.D., Ph.D. (+86 512 67781856, wudepei@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukemia-Free Survival (time frame: Five years). 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 5 Feb 2020.