ph+ Acute Lymphoblastic LeukemiaPhase 4TCLDCWTTNDPPNCT02690922
Low-dose Chemotherapy Combine With Tyrosine Kinase Inhibitor to Treat ph+ Acute Lymphoblastic Leukemia Patients
A Phase 4 study testing Dasatinib, prednisone and dexamethasone in people with ph+ Acute Lymphoblastic Leukemia, run by Tongji Hospital at 1 site in China.
Trial summary
The aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ph+ Acute Lymphoblastic Leukemia
- What is being tested?
- Dasatinib, prednisone and dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to May 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Get signed the informed consent of patients and family members
- Age ≥ 18 one full year of life
- Confirm the ph + ALL at molecular biology level
- Normal heart and lungs function
- Normal liver and kidney function
Who cannot join
- Leukemia in the nervous system
- Recurrent patients
- Allergies associated with any drug in our research
- At the same time with other organs' malignant tumours
- participating in other clinical researches at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients
The aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy drugs, lower the side effect brought by which this would be a grateful news for the patients once this regimens gain a successful result, which is also the final aim of our efforts.
Read the detailed description
The investigators new therapy regimens: The investigators use dexamethasone 10mg/d(d3-d7) as pre-processing therapy, dasatinib 100mg (d1-d84) plus prednisone 60mg/m2 (d1-24), reduce to d32, as inductive treatment after inductive treatment, if the patient get major molecular remission, patient will get to consolidation therapy, that is methotrexate (MTX) 3g/m2 d1, if not, this patient would be excluded from our trail. after consolidation therapy, if the patient have matched bone marrow donor, the investigators will suggest the patient receipting allogens-stem cell transplantation, otherwise, autogens stem cell transplantation can also be considered once the patient have no applicable bone marrow donor. on the other side, if the patient still not get MMR after this two cycle, maybe the patient can try Car-T, or other chemotherapy regimens.
- Conditions
- ph+ Acute Lymphoblastic Leukemia
- Being tested
- Dasatinib, prednisone, dexamethasone, methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel
100mg (d1-d84)
prednisoneDrug
Also called Pred
60mg/m2 d1-24
dexamethasoneDrug
Also called Decadron
10mg/d 3-7days
methotrexateDrug
Also called MTX
3g/m2 1day
| Study group | Role | What they receive |
|---|---|---|
| ph+ ALL with dasatinib | Experimental | patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy. Receives: Drug: Dasatinib; Drug: prednisone; Drug: dexamethasone; Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib
Measured: 115 days
Secondary outcomes (1)
Time needed to achieve MMR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ph+ Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Li, Tongji Hospital
- Investigators
- Li Meng, professor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690922
- Sponsor's protocol ID
- TJXYXXW
- Acronym
- TCLDCWTTNDPP
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.
PubMed 24357015Peng Y, Huang J, Yin J, Meng F, Cao Y, Huang L, Li D, Zhang Y, Zhang D, Meng L, Han Z, Hong Z. Frontline combination of dasatinib and low-intensity chemotherapy in adults with de novo Philadelphia chromosome-positive acute lymphoblastic leukemia. Expert Rev Hematol. 2024 Apr-May;17(4-5):173-180. doi: 10.1080/17474086.2024.2343885. Epub 2024 Apr 24.
PubMed 38616308
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients
- ClinicalTrials.gov ID
- NCT02690922
- Acronym / sponsor ID
- TCLDCWTTNDPP / TJXYXXW
- Conditions
- ph+ Acute Lymphoblastic Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- 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 aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy drugs, lower the side effect brought by which this would be a grateful news for the patients once this regimens gain a successful result, which is also the final aim of our efforts.
Detailed description
The investigators new therapy regimens: The investigators use dexamethasone 10mg/d(d3-d7) as pre-processing therapy, dasatinib 100mg (d1-d84) plus prednisone 60mg/m2 (d1-24), reduce to d32, as inductive treatment after inductive treatment, if the patient get major molecular remission, patient will get to consolidation therapy, that is methotrexate (MTX) 3g/m2 d1, if not, this patient would be excluded from our trail. after consolidation therapy, if the patient have matched bone marrow donor, the investigators will suggest the patient receipting allogens-stem cell transplantation, otherwise, autogens stem cell transplantation can also be considered once the patient have no applicable bone marrow donor. on the other side, if the patient still not get MMR after this two cycle, maybe the patient can try Car-T, or other chemotherapy regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ph+ ALL with dasatinib | Experimental | Drug: Dasatinib, Drug: prednisone, Drug: dexamethasone, Drug: methotrexatepatients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Get signed the informed consent of patients and family members
- Age ≥ 18 one full year of life
- Confirm the ph + ALL at molecular biology level
- Normal heart and lungs function
- Normal liver and kidney function
Key exclusion criteria (5 listed)
- Leukemia in the nervous system
- Recurrent patients
- Allergies associated with any drug in our research
- At the same time with other organs' malignant tumours
- participating in other clinical researches at the same time
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: Sprycel100mg (d1-d84) | Drug | ph+ ALL with dasatinib |
| prednisoneAlso: Pred60mg/m2 d1-24 | Drug | ph+ ALL with dasatinib |
| dexamethasoneAlso: Decadron10mg/d 3-7days | Drug | ph+ ALL with dasatinib |
| methotrexateAlso: MTX3g/m2 1day | Drug | ph+ ALL with dasatinib |
Primary outcome
The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib
Time frame: 115 days
1 secondary outcome
Time needed to achieve MMR
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Results publication: PubMed 24357015Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.
- Derived from this study: PubMed 38616308Peng Y, Huang J, Yin J, Meng F, Cao Y, Huang L, Li D, Zhang Y, Zhang D, Meng L, Han Z, Hong Z. Frontline combination of dasatinib and low-intensity chemotherapy in adults with de novo Philadelphia chromosome-positive acute lymphoblastic leukemia. Expert Rev Hematol. 2024 Apr-May;17(4-5):173-180. doi: 10.1080/17474086.2024.2343885. Epub 2024 Apr 24.
- Individual participant dataSharing planned: No
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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.
Li Meng, professor study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dasatinib, prednisone and dexamethasone in people with ph+ Acute Lymphoblastic Leukemia, run by Tongji Hospital 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 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: status not confirmed, as of the sponsor's last update on 24 Feb 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib (time frame: 115 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690922, which also lists 2 linked publications.
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 24 Feb 2016.