Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Phase 2NCT06658925
Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL
A Phase 2 study testing Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation. in people with Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) and HSCT, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell Transplantation Center of the Hospital of Hematology, Chinese Academy of Medical Sciences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), HSCT, Tyrosine Kinase Inhibitor
- What is being tested?
- Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Aug 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ( 1 ) Acute lymphoblastic leukemia with positive Ph chromosome or BCR / ABL fusion gene ; after allogeneic hematopoietic stem cell transplantation, and survived for more than 30 days after transplantation.
- ( 2 ) Age older than or equal to 18 years old ( 3 ) Informed consent can be signed by themselves. ( 4 ) Adequate organ function must be met : renal function and liver function are as follows : serum creatinine is 2 times lower than the normal upper limit, AST, ALT and ALP are lower than the normal upper limit of 3 times, and total bilirubin is lower than the normal upper limit of 3 times ( if the liver GVHD is clearly diagnosed, less than or equal to 5 × ULN ) ).
- ( 5 ) HIV negative, HBV and HCV negative. ( 6 ) The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.
- ( 7 ) Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Who cannot join
- ( 1 ) Hematology remission was evaluated at 1 month after transplantation, and complete donor chimerism was achieved.
- ( 2 ) Severe cardiovascular diseases ( including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure, etc. ) occurred during the previous use of the third generations of TKI treatment.
- ( 3 ) Uncontrolled infection at the time of enrollment ; severe complications of mechanical ventilation or hemodynamic instability ; those who had undergone autologous or allogeneic stem cell transplantation; ( 4 ) The serological reaction of known HIV or active hepatitis C virus is positive ; ( 5 ) suffering from mental illness or other illness and can not cooperate with the research treatment and monitoring requirements ; ( 6 ) being unable or unwilling to sign the consent ; ( 7 ) pregnant or lactating women ; ( 8 ) Patients with other special conditions who were assessed as unqualified by the researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Safety and Efficacy of Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Adult Ph + Acute Lymphoblastic Leukemia
This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell Transplantation Center of the Hospital of Hematology, Chinese Academy of Medical Sciences. The number of patients is expected to be 50 cases. The enrolled patients plan to receive Olverembatinib as a post-transplant treatment regimen, including maintenance therapy to prevent recurrence and preemptive treatment. Hematopoietic reconstitution ( neutrophil > 0.5 × 10 ^ 9 / L, platelet > 50 × 10 ^ 9 / L ) was evaluated after enrollment. From 2 months to 3 months after transplantation, Olverembatinib 40 mg QOD was added for maintenance treatment until 2 years after transplantation. During maintenance treatment, Olverembatinib dose ( dose range 20 mg QOD to 40 mg QOD ) can be adjusted according to blood picture, biochemical index or other oral drugs ( triazole drugs, etc. ).
- Being tested
- Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.Drug
Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Olverembatinib as maintenance therapy or preemptive therapy post-HSCT | Experimental | Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation. Receives: Drug: Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year RFS after transplantation
2-year relapse-free survival after transplantation
Measured: 2 year after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658925
- Sponsor's protocol ID
- IIT2024065
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Adult Ph + Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06658925
- Acronym / sponsor ID
- IIT2024065
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Oct 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.
This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell Transplantation Center of the Hospital of Hematology, Chinese Academy of Medical Sciences. The number of patients is expected to be 50 cases. The enrolled patients plan to receive Olverembatinib as a post-transplant treatment regimen, including maintenance therapy to prevent recurrence and preemptive treatment. Hematopoietic reconstitution ( neutrophil > 0.5 × 10 ^ 9 / L, platelet > 50 × 10 ^ 9 / L ) was evaluated after enrollment. From 2 months to 3 months after transplantation, Olverembatinib 40 mg QOD was added for maintenance treatment until 2 years after transplantation. During maintenance treatment, Olverembatinib dose ( dose range 20 mg QOD to 40 mg QOD ) can be adjusted according to blood picture, biochemical index or other oral drugs ( triazole drugs, etc. ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olverembatinib as maintenance therapy or preemptive therapy post-HSCT | Experimental | Drug: Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ( 1 ) Acute lymphoblastic leukemia with positive Ph chromosome or BCR / ABL fusion gene ; after allogeneic hematopoietic stem cell transplantation, and survived for more than 30 days after transplantation.
- ( 2 ) Age older than or equal to 18 years old ( 3 ) Informed consent can be signed by themselves. ( 4 ) Adequate organ function must be met : renal function and liver function are as follows : serum creatinine is 2 times lower than the normal upper limit, AST, ALT and ALP are lower than the normal upper limit of 3 times, and total bilirubin is lower than the normal upper limit of 3 times ( if the liver GVHD is clearly diagnosed, less than or equal to 5 × ULN ) ).
- ( 5 ) HIV negative, HBV and HCV negative. ( 6 ) The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.
- ( 7 ) Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Key exclusion criteria (3 listed)
- ( 1 ) Hematology remission was evaluated at 1 month after transplantation, and complete donor chimerism was achieved.
- ( 2 ) Severe cardiovascular diseases ( including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure, etc. ) occurred during the previous use of the third generations of TKI treatment.
- ( 3 ) Uncontrolled infection at the time of enrollment ; severe complications of mechanical ventilation or hemodynamic instability ; those who had undergone autologous or allogeneic stem cell transplantation; ( 4 ) The serological reaction of known HIV or active hepatitis C virus is positive ; ( 5 ) suffering from mental illness or other illness and can not cooperate with the research treatment and monitoring requirements ; ( 6 ) being unable or unwilling to sign the consent ; ( 7 ) pregnant or lactating women ; ( 8 ) Patients with other special conditions who were assessed as unqualified by the researchers.
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 |
|---|---|---|
| Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation. | Drug | Olverembatinib as maintenance therapy or preemptive therapy post-HSCT |
Primary outcome
2-year RFS after transplantation
Time frame: 2 year after HSCT
2-year relapse-free survival after transplantation
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 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation. in people with Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) and HSCT, run by Institute of Hematology & Blood Diseases Hospital, 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 3 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: opening soon, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Erlie Jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year RFS after transplantation (time frame: 2 year after HSCT). 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 Oct 2024.