Precursor Cell Lymphoblastic Leukemia-LymphomaNCT05024357
A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL
A study testing Dasatinib in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma and Philadelphia-Positive Acute Lymphoblastic Leukemia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi 'an Jiaotong University.Tyrosine kinase inhibitors (TKI) combined with chemotherapy and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) are routinely used in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia-Positive Acute Lymphoblastic Leukemia, ALL, Adult
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2021to 30 Jun 2023
- Phase
- Interventional
- 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
- 18-65 years old, newly diagnosed as Ph+ALL.
- Sign the informed consent.
- Have appropriate allo-HSCT donors.
- Accept allo-HSCT.
- Accept follow-up.
Who cannot join
- Liver and kidney function impairment: serum transaminase > 2 times of the upper limit of normal value, total bilirubin > 1.5 times of the upper limit of normal value, serum inosine > the upper limit of normal value (97 umol/L).
- Active hepatitis B, hepatitis C or tuberculosis infection.
- Can not tolerate the adverse effects of dasatinib.
- Pregnancy.
- Diagnosis of mental disorders.
- Failed to reach molecular complete remission (MCR) after the early treatment.
- Do not accept follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Pengcheng He, 0086-18991232609, hepc@163.com
Xiaoyan Zheng, 0086-15829370502, xiaoy_2008@126.com
About this study
Official title: A Randomized Controlled Study of Tyrosine Kinase Inhibitor Maintenance Therapy Following Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed Philadelphia Chromesome Positive Adult Acute Lymphoblastic Leukemia
This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi 'an Jiaotong University.Tyrosine kinase inhibitors (TKI) combined with chemotherapy and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) are routinely used in patients with philadelpha-positive lymphoblastic leukemia (Ph+ALL). However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled and given dasatinib combined with chemotherapy followed by allo-HSCT. Then patients in the group A continuing to use dasatinib for 1 year is compared with those in the group B receiving dasatinib for 6 months after HSCT. The measurable residual disease (MRD), complete remission (CR), overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.
Read the detailed description
About 25% of adult patients with acute lymphoblastic leukemia (ALL) are associated with t (9; 22), positive philadelphia chromosome (Ph+ ALL), in whom BCR/ABL fusion gene can be detected in the bone marrow and peripheral blood. Although current treatment strategies using tyrosine kinase inhibitors (TKIs) such as dasatinib combined with chemotherapy have achieved high complete remission (CR) rates, the duration of remission is short, and most Ph+ ALL patients relapse within 2 years. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) bridging to CR remains the only strategy to cure Ph+ ALL. However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled. The participants will receive dasatinib combined with induction and consolidation chemotherapy to obtain molecular remission and then undergo allo-HSCT. After the above treatments, the patients will be randomly divided into two groups. The subjects in the group A will continue to use dasatinib for 1 year, while the patients in the group B receive dasatinib for 6 months post-HSCT. The measurable residual disease (MRD), CR, overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.
- Conditions
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia-Positive Acute Lymphoblastic Leukemia, ALL, Adult
- Being tested
- Dasatinib
- Keywords
- Philadelphia-Positive, Adult Acute Lymphoblastic Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Tyrosine Kinase Inhibitors
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Dasatinib tablet
Take Dasatinib orally for 1 year or 6 months post-HSCT.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib for 1 year | Experimental | After the allo-HSCT treatment, the patients in this group will continue to take dasatinib orally for 1 year. Receives: Drug: Dasatinib |
| Dasatinib for 6 months | Experimental | After the allo-HSCT treatment, the patients in this group will receive dasatinib for 6 months. Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with Measurable Residual Disease (MRD) Positivity
MRD means the subclinical levels of residual leukemia.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Percentage of Patients with Complete Remission (CR)
CR means that the blood counts have returned to normal, the leukemia cannot be seen when a bone marrow sample is examined under the microscope, and the signs and symptoms of the ALL are gone.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Secondary outcomes (5)
Disease-free Survival (DFS), months
The measure of time after allo-HSCT during which no sign of ALL is found.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Overall Survival (OS), months
The length of time from the date of allo-HSCT that Ph+ ALL patients are still alive.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.
Non-relapse Mortality (NRM), rate or percentage
NRM means death without recurrent or progressive disease after allo-HSCT.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Incidence of graft versus host disease (GVHD), rate or percentage
GVHD is a condition that might occur after allo-HSCT. In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body.
Measured: From date of randomization until the date of GVHD occurrence or date of death from any cause, whichever came first, assessed up to 36 months.
Adverse Effects (AE)
An adverse effect is any untoward medical occurrence in clinical investigation subject administered dasatinib and which does not necessarily have a causal relationship with this treatment.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start6 Sep 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pengcheng He, Study chair, First Affiliated Hospital of Xian Jiaotong UniversityXiaoning Wang, Study director, First Affiliated Hospital of Xian Jiaotong UniversityHuachao Zhu, Principal investigator, First Affiliated Hospital of Xian Jiaotong UniversityJuan Ren, Principal investigator, First Affiliated Hospital of Xian Jiaotong UniversityYing Chen, Principal investigator, First Affiliated Hospital of Xian Jiaotong UniversityTing Fan, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024357
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-002-1
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 1 Oct 2021
- 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 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Tyrosine Kinase Inhibitor Maintenance Therapy Following Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed Philadelphia Chromesome Positive Adult Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05024357
- Acronym / sponsor ID
- XJTU1AF-CRF-2020-002-1
- Conditions
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia-Positive Acute Lymphoblastic Leukemia, ALL, Adult
- Keywords
- Philadelphia-Positive, Adult Acute Lymphoblastic Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Tyrosine Kinase Inhibitors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Aug 2021 (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 project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi 'an Jiaotong University.Tyrosine kinase inhibitors (TKI) combined with chemotherapy and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) are routinely used in patients with philadelpha-positive lymphoblastic leukemia (Ph+ALL). However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled and given dasatinib combined with chemotherapy followed by allo-HSCT. Then patients in the group A continuing to use dasatinib for 1 year is compared with those in the group B receiving dasatinib for 6 months after HSCT. The measurable residual disease (MRD), complete remission (CR), overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.
Detailed description
About 25% of adult patients with acute lymphoblastic leukemia (ALL) are associated with t (9; 22), positive philadelphia chromosome (Ph+ ALL), in whom BCR/ABL fusion gene can be detected in the bone marrow and peripheral blood. Although current treatment strategies using tyrosine kinase inhibitors (TKIs) such as dasatinib combined with chemotherapy have achieved high complete remission (CR) rates, the duration of remission is short, and most Ph+ ALL patients relapse within 2 years. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) bridging to CR remains the only strategy to cure Ph+ ALL. However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled. The participants will receive dasatinib combined with induction and consolidation chemotherapy to obtain molecular remission and then undergo allo-HSCT. After the above treatments, the patients will be randomly divided into two groups. The subjects in the group A will continue to use dasatinib for 1 year, while the patients in the group B receive dasatinib for 6 months post-HSCT. The measurable residual disease (MRD), CR, overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasatinib for 1 year | Experimental | Drug: DasatinibAfter the allo-HSCT treatment, the patients in this group will continue to take dasatinib orally for 1 year. |
| Dasatinib for 6 months | Experimental | Drug: DasatinibAfter the allo-HSCT treatment, the patients in this group will receive dasatinib for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old, newly diagnosed as Ph+ALL.
- Sign the informed consent.
- Have appropriate allo-HSCT donors.
- Accept allo-HSCT.
- Accept follow-up.
Key exclusion criteria (7 listed)
- Liver and kidney function impairment: serum transaminase > 2 times of the upper limit of normal value, total bilirubin > 1.5 times of the upper limit of normal value, serum inosine > the upper limit of normal value (97 umol/L).
- Active hepatitis B, hepatitis C or tuberculosis infection.
- Can not tolerate the adverse effects of dasatinib.
- Pregnancy.
- Diagnosis of mental disorders.
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 |
|---|---|---|
| DasatinibAlso: Dasatinib tabletTake Dasatinib orally for 1 year or 6 months post-HSCT. | Drug | Dasatinib for 1 year, Dasatinib for 6 months |
Primary outcome
Percentage of Patients with Measurable Residual Disease (MRD) Positivity
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
MRD means the subclinical levels of residual leukemia.
Percentage of Patients with Complete Remission (CR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
CR means that the blood counts have returned to normal, the leukemia cannot be seen when a bone marrow sample is examined under the microscope, and the signs and symptoms of the ALL are gone.
5 secondary outcomes
Disease-free Survival (DFS), months
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Overall Survival (OS), months
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.
Non-relapse Mortality (NRM), rate or percentage
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Incidence of graft versus host disease (GVHD), rate or percentage
Time frame: From date of randomization until the date of GVHD occurrence or date of death from any cause, whichever came first, assessed up to 36 months.
Adverse Effects (AE)
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
Related trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Pengcheng He study chair
First Affiliated Hospital of Xian Jiaotong University
Xiaoning Wang study director
First Affiliated Hospital of Xian Jiaotong University
Huachao Zhu principal investigator
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dasatinib in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma and Philadelphia-Positive Acute Lymphoblastic Leukemia, run by First Affiliated Hospital Xi'an Jiaotong 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. 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.
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 Pengcheng He (0086-18991232609, hepc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with Measurable Residual Disease (MRD) Positivity (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.). The study lists 2 primary outcomes in all. 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 1 Oct 2021.