Precursor Cell Lymphoblastic Leukemia-LymphomaNCT05026229
A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in Ph+ Adult ALL
A study testing dasatinib plus consolidation chemotherapy with vincristine and prednisone and dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine 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 intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). 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 plus consolidation chemotherapy with vincristine and prednisone and dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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.
- Accept consolidation chemotherapy.
- 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.
- 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 Dasatinib Combined With Reduced Intensive Consolidation Chemotherapy in Newly Diagosed Philadelphia Chromesome Positive Adult 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 intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). However, a considerable proportion of patients failed to complete the intended chemotherapy and some even died early. The optimal balance between the intensity of chemotherapy and safety should be explored. In this study, Ph+ ALL patients who achieve complete remission (CR) after VP regimen (vincristine and prednisone) plus dasatinib as induction are enrolled and then the participants will receive different consolidation chemotherapy. Patients in the group A will continue to use VP regimen plus dasatinib, while the group B receives hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.
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. The use of tyrosine kinase inhibitors (TKI) plus intensive chemotherapy has markedly improved the outcomes of Ph+ ALL. However, it's reported that 74% pf patients failed to complete the intended chemotherapy, and early death occured in a considerable proportion of patients during induction. The optimal balance between the intensity of chemotherapy and safety need to be explored. In this study, Ph+ ALL patients are enrolled. The participants will receive dasatinib and induction chemotherapy using VP regimen (vincristine and prednisone) to achieve complete remission (CR). Then the participants will be randomly divided into two groups. The subjects inthe group A will continue to use VP regimen plus dasatinib as consolidation, while the patients in the group B receive hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.
- Conditions
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia-Positive Acute Lymphoblastic Leukemia, ALL, Adult
- Being tested
- dasatinib plus consolidation chemotherapy with vincristine and prednisone, dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine
- Keywords
- Philadelphia-Positive, Adult Acute Lymphoblastic Leukemia, Tyrosine Kinase Inhibitor, Consolidation Chemotherapy
- 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.
dasatinib plus consolidation chemotherapy with vincristine and prednisoneDrug
Also called Dasatinib + VP Regimen
After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone.
dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabineDrug
Also called Dasatinib + HyperB Regimen
After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib, Vincristine and Prednisone | Experimental | After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone. Receives: Drug: dasatinib plus consolidation chemotherapy with vincristine and prednisone |
| Dasatinib, Methotrexate and Cytarabine | Experimental | After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine. Receives: Drug: dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Measurable Residual Disease (MRD) Positivity
MRD refers to 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 Participants 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 (3)
disease-free survival (DFS), months
The measure of time after consolidation chemotherapy during which no sign of ALL is found.
Measured: From date of consolidation chemotherapy until disease progression, the end of follow-up or the date of death from any cause, whichever came first.
overall survival (OS), months
The length of time from the date of diagnosis that Ph+ ALL patients are still alive.
Measured: From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.
adverse effects (AE)
An adverse effect is any untoward medical occurrence in clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 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
- 60 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
- NCT05026229
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-002-2
- 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 Dasatinib Combined With Reduced Intensive Consolidation Chemotherapy in Newly Diagosed Philadelphia Chromesome Positive Adult Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05026229
- Acronym / sponsor ID
- XJTU1AF-CRF-2020-002-2
- Conditions
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia-Positive Acute Lymphoblastic Leukemia, ALL, Adult
- Keywords
- Philadelphia-Positive, Adult Acute Lymphoblastic Leukemia, Tyrosine Kinase Inhibitor, Consolidation Chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 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
- 30 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 intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). However, a considerable proportion of patients failed to complete the intended chemotherapy and some even died early. The optimal balance between the intensity of chemotherapy and safety should be explored. In this study, Ph+ ALL patients who achieve complete remission (CR) after VP regimen (vincristine and prednisone) plus dasatinib as induction are enrolled and then the participants will receive different consolidation chemotherapy. Patients in the group A will continue to use VP regimen plus dasatinib, while the group B receives hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.
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. The use of tyrosine kinase inhibitors (TKI) plus intensive chemotherapy has markedly improved the outcomes of Ph+ ALL. However, it's reported that 74% pf patients failed to complete the intended chemotherapy, and early death occured in a considerable proportion of patients during induction. The optimal balance between the intensity of chemotherapy and safety need to be explored. In this study, Ph+ ALL patients are enrolled. The participants will receive dasatinib and induction chemotherapy using VP regimen (vincristine and prednisone) to achieve complete remission (CR). Then the participants will be randomly divided into two groups. The subjects inthe group A will continue to use VP regimen plus dasatinib as consolidation, while the patients in the group B receive hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasatinib, Vincristine and Prednisone | Experimental | Drug: dasatinib plus consolidation chemotherapy with vincristine and prednisoneAfter induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone. |
| Dasatinib, Methotrexate and Cytarabine | Experimental | Drug: dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabineAfter induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old, newly diagnosed as Ph+ALL.
- Sign the informed consent.
- Accept consolidation chemotherapy.
- Accept follow-up.
Key exclusion criteria (6 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 |
|---|---|---|
| dasatinib plus consolidation chemotherapy with vincristine and prednisoneAlso: Dasatinib + VP RegimenAfter induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone. | Drug | Dasatinib, Vincristine and Prednisone |
| dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabineAlso: Dasatinib + HyperB RegimenAfter induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine. | Drug | Dasatinib, Methotrexate and Cytarabine |
Primary outcome
Percentage of Participants 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 refers to the subclinical levels of residual leukemia.
Percentage of Participants 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.
3 secondary outcomes
disease-free survival (DFS), months
Time frame: From date of consolidation chemotherapy until disease progression, the end of follow-up or the date of death from any cause, whichever came first.
overall survival (OS), months
Time frame: From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.
adverse effects (AE)
Time frame: From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.
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.
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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.
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 plus consolidation chemotherapy with vincristine and prednisone and dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine 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 4 inclusion and 6 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 Participants 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.