Hematopoietic Stem Cell TransplantationPhase 3NCT03719534
Haplo HCT vs Haplo-cord HCT for Patients With AML
A Phase 3 study testing haplo-HCT and haplo-cord HCT in people with Hematopoietic Stem Cell Transplantation and Haplo-identical Donor, run by The First Affiliated Hospital of Soochow University at 5 sites in China.
Trial summary
Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Haplo-identical Donor, Cord Blood Unit
- What is being tested?
- haplo-HCT and haplo-cord HCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jun 2017to 31 Mar 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years old;
- Patients with AML;
- With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR)
- Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor
- With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Signing informed consent form, having the ability to comply with study and follow-up procedures
Who cannot join
- Acute promyelocytic leukaemia (AML subtype M3)
- With other malignances
- Failing to acquire a suitable UCB unit
- With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy
- With uncontrolled infection intolerant to haplo-HCT
- With severe organ dysfunction
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- Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- Respiratory failure (PaO2≤60 mmHg)
- Hepatic abnormalities (total bilirubin≥2×upper limit of normal [ULN], alanine aminotransferase or aspartate aminotransferase≥2×ULN)
- Renal dysfunction (creatinine≥2 mg/dL creatinine clearance rate < 30 mL/min)
- In pregnancy or lactation period
- With any conditions not suitable for the trial (investigators' decision)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
The Second People's Hospital of Huai'an
Huai'an, Jiangsu, 223000
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Soochow Hopes Hematology Hospital
Suzhou, Jiangsu, 215100
Hygeia Suzhou Yongding Hospital
Suzhou, Jiangsu, 215200
About this study
Official title: An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation
Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.
- Conditions
- Hematopoietic Stem Cell Transplantation, Haplo-identical Donor, Cord Blood Unit, Acute Myeloid Leukemia
- Being tested
- haplo-HCT, haplo-cord HCT
- 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.
haplo-HCTProcedure or surgery
HCT will be performed with a haploidentical donor
haplo-cord HCTProcedure or surgery
Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit
| Study group | Role | What they receive |
|---|---|---|
| Haplo-HCT | Active comparator | people enrolled in this arm will receive a typical haploidentical donor HCT Receives: Procedure: haplo-HCT |
| Haplo-cord HCT | Experimental | people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT Receives: Procedure: haplo-cord HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
estimated overall survival at 3 year
Measured: 3 year after randomization
Secondary outcomes (3)
Progression-free survival
estimated progression-free survival at 3 year
Measured: 3 year after randomization
Cumulative incidence of relapse
estimated cumulative incidence of nonrelapse mortality at 3 year
Measured: 3 year after randomization
Cumulative incidence of non-relapse mortality
estimated nonrelapse mortality at 3 year
Measured: 3 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
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 Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, The Second People's Hospital of Huai'an, Soochow Hopes Hematology Hospital, Hygeia Suzhou Yongding Hospital
- 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
- NCT03719534
- Sponsor's protocol ID
- SZ3703
- Status last verified
- Jun 2023
- First submitted
- 22 Oct 2018
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou B, Chen J, Liu T, Ye Y, Zhang Y, Ding Y, Liu H, Zhu M, Ma X, Li X, Zhao L, Lin Z, Huang H, Xu Y, Wu D. Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia: a multicenter, randomized, open-label, phase 3 trial. Signal Transduct Target Ther. 2024 May 6;9(1):108. doi: 10.1038/s41392-024-01820-5.
PubMed 38705885
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT03719534
- Acronym / sponsor ID
- SZ3703
- Conditions
- Hematopoietic Stem Cell Transplantation, Haplo-identical Donor, Cord Blood Unit, Acute Myeloid Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Zhejiang University, The Second People's Hospital of Huai'an, Soochow Hopes Hematology Hospital, Hygeia Suzhou Yongding Hospital
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 Oct 2018 (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.
Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haplo-HCT | Active comparator | Procedure: haplo-HCTpeople enrolled in this arm will receive a typical haploidentical donor HCT |
| Haplo-cord HCT | Experimental | Procedure: haplo-cord HCTpeople enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 60 years old;
- Patients with AML;
- With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR)
- Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor
- With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
Key exclusion criteria (12 listed)
- Acute promyelocytic leukaemia (AML subtype M3)
- With other malignances
- Failing to acquire a suitable UCB unit
- With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy
- With uncontrolled infection intolerant to haplo-HCT
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 |
|---|---|---|
| haplo-HCTHCT will be performed with a haploidentical donor | Procedure or surgery | Haplo-HCT |
| haplo-cord HCTHaploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit | Procedure or surgery | Haplo-cord HCT |
Primary outcome
Overall survival
Time frame: 3 year after randomization
estimated overall survival at 3 year
3 secondary outcomes
Progression-free survival
Time frame: 3 year after randomization
Cumulative incidence of relapse
Time frame: 3 year after randomization
Cumulative incidence of non-relapse mortality
Time frame: 3 year after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 38705885Zhou B, Chen J, Liu T, Ye Y, Zhang Y, Ding Y, Liu H, Zhu M, Ma X, Li X, Zhao L, Lin Z, Huang H, Xu Y, Wu D. Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia: a multicenter, randomized, open-label, phase 3 trial. Signal Transduct Target Ther. 2024 May 6;9(1):108. doi: 10.1038/s41392-024-01820-5.
- 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.
Depei Wu, M.D., Ph.D. principal investigator
The First Affiliated Hospital of Soochow University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing haplo-HCT and haplo-cord HCT in people with Hematopoietic Stem Cell Transplantation and Haplo-identical Donor, run by The First Affiliated Hospital of Soochow University at 5 sites 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 year after randomization). 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 NCT03719534, 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 27 Jun 2023.