Acute T Cell Lymphoblastic LeukemiaPhase 3NCT06381817
Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients
A Phase 3 study testing Haplo-cord HCT and Haplo-HCT in people with Acute T Cell Lymphoblastic Leukemia and Haploidentical Hematopoietic Stem Cell Transplantation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute T Cell Lymphoblastic Leukemia, Haploidentical Hematopoietic Stem Cell Transplantation, Cord Blood
- What is being tested?
- Haplo-cord HCT and Haplo-HCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute T cell lymphoblastic leukemia
- With available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction
- Willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor
- With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Signing an informed consent form, having the ability to comply with study and follow-up procedures
Who cannot join
- With other malignancies
- Failing to acquire a suitable unrelated cord blood unit
- With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy
- With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation
- With severe organ dysfunction
- In pregnancy or lactation period
- With any conditions not suitable for the trial (investigators' decision)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Yang XU, 86+051267781850, xuyang1020@126.com
Yang Xu
About this study
Official title: Haploidentical Hematopoietic Cell Transplantation Combined With an Unrelated Cord Blood Unit for Acute T Cell Lymphoblastic Leukemia Compared to Haploidentical Hematopoietic Cell Transplantation: a Multicenter, Randomized, Open-label Trial
The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:
Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.
Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.
- Conditions
- Acute T Cell Lymphoblastic Leukemia, Haploidentical Hematopoietic Stem Cell Transplantation, Cord Blood
- Being tested
- Haplo-cord HCT, Haplo-HCT
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haplo-cord HCTBiological
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
Haplo-HCTBiological
Hematopoietic cell transplantation will be performed with a haploidentical donor
| Study group | Role | What they receive |
|---|---|---|
| Haplo-cord HCT | Experimental | Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation Receives: Biological: Haplo-cord HCT |
| Haplo-HCT | Active comparator | Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation Receives: Biological: Haplo-HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
estimated progression-free survival at 2 year
Measured: 2 years after randomization
Secondary outcomes (4)
Overall survival
estimated overall survival at 2 year
Measured: 2 years after randomization
Cumulative incidence of relapse
estimated cumulative incidence of relapse at 2 year
Measured: 2 years after randomization
Non-relapse mortality
estimated non-relapse mortality at 2 year
Measured: 2 years after randomization
Adverse events
Number of participants with adverse events. Frequencies of toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) will be tabulated.
Measured: 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute T Cell Lymphoblastic LeukemiaStudies 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
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Soochow University, Ruijin Hospital, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, First Affiliated Hospital Xi'an Jiaotong University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Yang XU, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381817
- Sponsor's protocol ID
- 2024112
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haploidentical Hematopoietic Cell Transplantation Combined With an Unrelated Cord Blood Unit for Acute T Cell Lymphoblastic Leukemia Compared to Haploidentical Hematopoietic Cell Transplantation: a Multicenter, Randomized, Open-label Trial
- ClinicalTrials.gov ID
- NCT06381817
- Acronym / sponsor ID
- 2024112
- Conditions
- Acute T Cell Lymphoblastic Leukemia, Haploidentical Hematopoietic Stem Cell Transplantation, Cord Blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Soochow University, Ruijin Hospital, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, First Affiliated Hospital Xi'an Jiaotong University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Apr 2024 (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 goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:
Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.
Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haplo-cord HCT | Experimental | Biological: Haplo-cord HCTPatients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation |
| Haplo-HCT | Active comparator | Biological: Haplo-HCTPatients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with acute T cell lymphoblastic leukemia
- With available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction
- Willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor
- With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Signing an informed consent form, having the ability to comply with study and follow-up procedures
Key exclusion criteria (7 listed)
- With other malignancies
- Failing to acquire a suitable unrelated cord blood unit
- With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy
- With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation
- With severe organ dysfunction
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-cord HCTHaploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit | Biological | Haplo-cord HCT |
| Haplo-HCTHematopoietic cell transplantation will be performed with a haploidentical donor | Biological | Haplo-HCT |
Primary outcome
Progression-free survival
Time frame: 2 years after randomization
estimated progression-free survival at 2 year
4 secondary outcomes
Overall survival
Time frame: 2 years after randomization
Cumulative incidence of relapse
Time frame: 2 years after randomization
Non-relapse mortality
Time frame: 2 years after randomization
Adverse events
Time frame: 2 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
Yang XU 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 Haplo-cord HCT and Haplo-HCT in people with Acute T Cell Lymphoblastic Leukemia and Haploidentical Hematopoietic Stem Cell Transplantation, 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang XU (86+051267781850, xuyang1020@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years after randomization). 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 26 Apr 2024.