Prophylactic HQP1351 TherapyPhase 2Case-OnlyNCT05604755
Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT
A Phase 2 study testing HQP1351( Olverembatinib dimesylate) in people with Prophylactic HQP1351 Therapy and Third Generation TKI, run by xuna at 1 site in China.
Trial summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prophylactic HQP1351 Therapy, Third Generation TKI
- What is being tested?
- HQP1351( Olverembatinib dimesylate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age of 18-65 years
- Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants
- Survival > 30 days post-transplants
- Laboratory parameters as defined below:
- Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD),Total bilirubin less than or equal to 3 x ULN
- Ability to understand and willingness to sign a written informed consent form
Who cannot join
- Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
- Survival <30 days post-transplants
- MRD positive on day +30 post-transplants
- 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
Department of Hematology, Nanfang Hospital, Southern Medical University,
Guanzhou
About this study
Official title: Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ luekemia. In this study, we will evaluate the safety and efficacy of newly third TKI-HQP1351 therapy post-transplants on Ph+ leukemia after allo-HSCT with MRD positive pre-transplants.
- Conditions
- Prophylactic HQP1351 Therapy, Third Generation TKI
- Being tested
- HQP1351( Olverembatinib dimesylate)
- Keywords
- CML, ph+ ALL, HQP1351, Prophylactic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HQP1351( Olverembatinib dimesylate)Drug
HQP1351 was initiated at a dose of 40mg every two days
| Study group | Role | What they receive |
|---|---|---|
| HQP1351 prophylactic therapy | Experimental | HQP1351 prophylactic therapy after allo-hct on days 30 to 60 Receives: Drug: HQP1351( Olverembatinib dimesylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival（DFS）
The time from the date of transplantation to leukemia relapse
Measured: 2 years
Secondary outcomes (3)
Overall survival(OS)
the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up The time from the date of transplantation to death or the last day of follow-up
Measured: 2 years
Relapse rate
the cumulative relapse rate of leukemia
Measured: 2 years
Adverse effects of TKI therapy
Number of participants with treatment-related adverse events
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 posted3 Nov 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Drugs was too expensive eligible for inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylactic HQP1351 TherapyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- xuna
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Guangdong Second Provincial General Hospital
- Responsible party
- Sponsor-investigator, xuna, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604755
- Sponsor's protocol ID
- PH20221030
- Acronym
- Case-Only
- Status last verified
- Jan 2023
- First submitted
- 30 Oct 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants
- ClinicalTrials.gov ID
- NCT05604755
- Acronym / sponsor ID
- Case-Only / PH20221030
- Conditions
- Prophylactic HQP1351 Therapy, Third Generation TKI
- Keywords
- CML, ph+ ALL, HQP1351, Prophylactic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drugs was too expensive eligible for inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- xunaUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Guangdong Second Provincial General Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Nov 2022 (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.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ luekemia. In this study, we will evaluate the safety and efficacy of newly third TKI-HQP1351 therapy post-transplants on Ph+ leukemia after allo-HSCT with MRD positive pre-transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HQP1351 prophylactic therapy | Experimental | Drug: HQP1351( Olverembatinib dimesylate)HQP1351 prophylactic therapy after allo-hct on days 30 to 60 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age of 18-65 years
- Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants
- Survival > 30 days post-transplants
- Laboratory parameters as defined below:
- Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD),Total bilirubin less than or equal to 3 x ULN
Key exclusion criteria (5 listed)
- Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
- Survival <30 days post-transplants
- MRD positive on day +30 post-transplants
- 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 |
|---|---|---|
| HQP1351( Olverembatinib dimesylate)HQP1351 was initiated at a dose of 40mg every two days | Drug | HQP1351 prophylactic therapy |
Primary outcome
Disease Free Survival（DFS）
Time frame: 2 years
The time from the date of transplantation to leukemia relapse
3 secondary outcomes
Overall survival(OS)
Time frame: 2 years
Relapse rate
Time frame: 2 years
Adverse effects of TKI therapy
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HQP1351( Olverembatinib dimesylate) in people with Prophylactic HQP1351 Therapy and Third Generation TKI, run by xuna 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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Jan 2023. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Disease Free Survival（DFS） (time frame: 2 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 18 Jan 2023.