BortezomibPhase 1NCT05982756
Bortezomib Combined With DAG Regimen in the Treatment of Refractory/Relapsed AML
A Phase 1 study testing DAG pre-excitation regimen with Bortezomib in people with Bortezomib and Acute Myeloid Leukemia, run by Zhongnan Hospital at 1 site in China.
Trial summary
In recent years, the efficacy of AML has been greatly improved, which is mainly due to the following aspects: the development of individualized treatment strategies based on genetic prognosis stratification, the application of high-dose cytarabine-containing induction and consolidation regimens , the choice of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bortezomib, Acute Myeloid Leukemia
- What is being tested?
- DAG pre-excitation regimen with Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Dec 2023
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with AML confirmed by bone marrow morphology and immunology
- Patients who do not respond or relapse after conventional treatment
- Age 18-75
- Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal value, 451 μmol/L ≥ serum creatinine ≥ 133 μmol/L, 80 ml/min ≥ creatinine clearance ≥ 20ml/min
- Cardiac function index EF value ≥ 50%
- Physical condition score 0-2 (ECOG score)
- Obtain signed informed consent from patients or family members
Who cannot join
- Allergies or obvious contraindications to any of the drugs involved in the program
- Severe heart disease, including myocardial infarction and cardiac insufficiency.
- Suffering from other organ malignancies at the same time
- Active tuberculosis patients and HIV positive patients
- Suffering from other blood system diseases at the same time
- Pregnant or lactating women
- Inability to understand or follow the research protocol
- 1. Past history of intolerance or allergy to similar drugs 2. Patients under 18 years old or over 75 years old 3. Simultaneously participate in other clinical investigators 4. Any other circumstances that prevent the conduct of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhou Fuling, director, +86-02767813137, zhoufuling@163.com
About this study
Official title: A Prospective Randomized Controlled Clinical Study of Bortezomib Combined With DAG Regimen in the Treatment of Refractory/Relapsed AML
In recent years, the efficacy of AML has been greatly improved, which is mainly due to the following aspects: the development of individualized treatment strategies based on genetic prognosis stratification, the application of high-dose cytarabine-containing induction and consolidation regimens , the choice of allogeneic or autologous hematopoietic stem cell transplantation, etc. However, 20%-30% of young patients and 40%-50% of elderly patients will relapse again, and 20%-40% of patients cannot be relieved after standard induction regimens, that is, relapsed and refractory AML. The re-induction remission rate is low, the survival period is short, and the prognosis is extremely poor. There is still a lack of standard treatment options. Although a small number of patients can benefit from allogeneic hematopoietic stem cell transplantation (allo-HSCT), most patients lack suitable donors. The choice of high-dose chemotherapy is a salvage treatment option, but treatment-related hematological or non-hematological toxicities and high lethality make the option controversial, especially for the elderly. The development of new low-toxic targeted drugs is a future trend, and the design of new efficient and safe chemotherapy regimens is also a way of thinking. This study designed a prospective single-center clinical randomized controlled study plan, that is, the use of bortezomib (1.3mg/m2, d1, 4, 8, 11) combined with DAG regimen in the treatment of refractory/relapsed AML, to evaluate the clinical efficacy (complete remission rate , total effective rate, 2-year progression-free survival rate and 2-year overall survival rate), and observe how safe the new program is. The results of the research will make it possible to design a high-efficiency, low-toxicity and high-feasibility chemotherapy regimen for refractory/relapsed patients, and guide the clinical treatment of relapsed/refractory acute leukemia.
Read the detailed description
This study aimed to evaluate the clinical efficacy of bortezomib combined with DAG regimen in the treatment of refractory and relapsed AML (complete remission rate, overall effective rate, 2-year progression-free survival rate and 2-year overall survival rate), and to compare the effects of the two regimens. Safety, guiding the clinical treatment of relapsed/refractory acute leukemia. For the smooth development of this study, the relevant monitoring indicators of the study are as follows:
- Select suitable subjects with relapsed/refractory acute myeloid leukemia according to the inclusion criteria, and explain the treatment indications of bortezomib and the purpose of this clinical study to the subjects and their families.
- The attending doctor communicates with the subject and his family members according to the condition of the subject and signs the informed consent. The subject needs to perform the following tests: three routine tests, cerebrospinal fluid routine and biochemistry, liver function, kidney function, PNH test, anemia four Items (ferritin, folic acid, vitamin B12, erythropoietin), blood sugar, blood lipids, electrolytes, myocardial enzymes, coagulation function, HIV antibody, syphilis, screening of related hepatitis virus markers, tumor markers, chest X-ray, Electrocardiogram, CT or MRI examination, etc.; if conditions permit, immune function and T cell subsets can be monitored.
- Clinical research: According to the research design, this clinical research was carried out, and relevant indicators such as the incidence of third-degree and fourth-degree myelosuppression and infection after chemotherapy, the rate of antibiotic use, the delay rate of chemotherapy, and the extension time of chemotherapy were recorded. The incidence and severity of adverse drug reactions were recorded.
- Conditions
- Bortezomib, Acute Myeloid Leukemia
- Being tested
- DAG pre-excitation regimen with Bortezomib
- Keywords
- pre-excitation regimen, acute myeloid leukemi, Bortezomib
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAG pre-excitation regimen with BortezomibDrug
Also called Bortezomib group
Bortezomib+DAG pre-excitation regimen: Bortezomib (specification 3.5mg, intravenous injection, 4 times a course of treatment, 1.3mg/m2, d1, 4, 8, 11; doxorubicin liposome injection 5 mg/ m2, intravenous infusion, once every other day, 5 times in total; cytarabine 10 mg/m2 every 12 hours, subcutaneous injection, d1-14; G-CSF 200 μg/m2 daily, subcutaneous injection, d1-14 Days, WBC >10×109/L during chemotherapy, postpone the use until it falls below this value;
| Study group | Role | What they receive |
|---|---|---|
| Test group: Induction treatment plan A | Experimental | Bortezomib+DAG pre-excitation regimen Receives: Drug: DAG pre-excitation regimen with Bortezomib |
| Control group: induction regimen B | Active comparator | DAG pre-excitation plan alone Receives: Drug: DAG pre-excitation regimen with Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate Rate of bone marrow blasts
Bone marrow blasts <20%
Measured: Evaluation at the 4th weekend after the end of all chemotherapy cycles
Secondary outcomes (5)
blood routine
differential blood count
Measured: Evaluation at the 4th weekend after the end of all chemotherapy cycles
liver function
Detection of hepatic metabolite concentration in blood
Measured: Evaluation at the 4th weekend after the end of all chemotherapy cycles
Recovery time
Recovery time of patients' neutrophils, hemoglobin and platelets
Measured: Evaluation at the 4th weekend after the end of all chemotherapy cycles
The incidence of complications in patients
The incidence of complications in patients
Measured: Evaluation at the 4th weekend after the end of all chemotherapy cycles
kidney function
Urine composition analysis
Measured: Evaluation at the 4th weekend after the end of all chemotherapy cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Jan 2020
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BortezomibStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuling Zhou, phD, Study director, Wuhan UniversityTIANZHI WU, phD, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982756
- Sponsor's protocol ID
- 04
- Status last verified
- Mar 2023
- First submitted
- 13 Jul 2023
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Study of Bortezomib Combined With DAG Regimen in the Treatment of Refractory/Relapsed AML
- ClinicalTrials.gov ID
- NCT05982756
- Acronym / sponsor ID
- 04
- Conditions
- Bortezomib, Acute Myeloid Leukemia
- Keywords
- pre-excitation regimen, acute myeloid leukemi, Bortezomib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 9 Aug 2023 (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.
In recent years, the efficacy of AML has been greatly improved, which is mainly due to the following aspects: the development of individualized treatment strategies based on genetic prognosis stratification, the application of high-dose cytarabine-containing induction and consolidation regimens , the choice of allogeneic or autologous hematopoietic stem cell transplantation, etc. However, 20%-30% of young patients and 40%-50% of elderly patients will relapse again, and 20%-40% of patients cannot be relieved after standard induction regimens, that is, relapsed and refractory AML. The re-induction remission rate is low, the survival period is short, and the prognosis is extremely poor. There is still a lack of standard treatment options. Although a small number of patients can benefit from allogeneic hematopoietic stem cell transplantation (allo-HSCT), most patients lack suitable donors. The choice of high-dose chemotherapy is a salvage treatment option, but treatment-related hematological or non-hematological toxicities and high lethality make the option controversial, especially for the elderly. The development of new low-toxic targeted drugs is a future trend, and the design of new efficient and safe chemotherapy regimens is also a way of thinking. This study designed a prospective single-center clinical randomized controlled study plan, that is, the use of bortezomib (1.3mg/m2, d1, 4, 8, 11) combined with DAG regimen in the treatment of refractory/relapsed AML, to evaluate the clinical efficacy (complete remission rate , total effective rate, 2-year progression-free survival rate and 2-year overall survival rate), and observe how safe the new program is. The results of the research will make it possible to design a high-efficiency, low-toxicity and high-feasibility chemotherapy regimen for refractory/relapsed patients, and guide the clinical treatment of relapsed/refractory acute leukemia.
Detailed description
This study aimed to evaluate the clinical efficacy of bortezomib combined with DAG regimen in the treatment of refractory and relapsed AML (complete remission rate, overall effective rate, 2-year progression-free survival rate and 2-year overall survival rate), and to compare the effects of the two regimens. Safety, guiding the clinical treatment of relapsed/refractory acute leukemia. For the smooth development of this study, the relevant monitoring indicators of the study are as follows:
- Select suitable subjects with relapsed/refractory acute myeloid leukemia according to the inclusion criteria, and explain the treatment indications of bortezomib and the purpose of this clinical study to the subjects and their families.
- The attending doctor communicates with the subject and his family members according to the condition of the subject and signs the informed consent. The subject needs to perform the following tests: three routine tests, cerebrospinal fluid routine and biochemistry, liver function, kidney function, PNH test, anemia four Items (ferritin, folic acid, vitamin B12, erythropoietin), blood sugar, blood lipids, electrolytes, myocardial enzymes, coagulation function, HIV antibody, syphilis, screening of related hepatitis virus markers, tumor markers, chest X-ray, Electrocardiogram, CT or MRI examination, etc.; if conditions permit, immune function and T cell subsets can be monitored.
- Clinical research: According to the research design, this clinical research was carried out, and relevant indicators such as the incidence of third-degree and fourth-degree myelosuppression and infection after chemotherapy, the rate of antibiotic use, the delay rate of chemotherapy, and the extension time of chemotherapy were recorded. The incidence and severity of adverse drug reactions were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group: Induction treatment plan A | Experimental | Drug: DAG pre-excitation regimen with BortezomibBortezomib+DAG pre-excitation regimen |
| Control group: induction regimen B | Active comparator | Drug: DAG pre-excitation regimen with BortezomibDAG pre-excitation plan alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with AML confirmed by bone marrow morphology and immunology
- Patients who do not respond or relapse after conventional treatment
- Age 18-75
- Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal value, 451 μmol/L ≥ serum creatinine ≥ 133 μmol/L, 80 ml/min ≥ creatinine clearance ≥ 20ml/min
- Cardiac function index EF value ≥ 50%
Key exclusion criteria (8 listed)
- Allergies or obvious contraindications to any of the drugs involved in the program
- Severe heart disease, including myocardial infarction and cardiac insufficiency.
- Suffering from other organ malignancies at the same time
- Active tuberculosis patients and HIV positive patients
- Suffering from other blood system diseases 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 |
|---|---|---|
| DAG pre-excitation regimen with BortezomibAlso: Bortezomib groupBortezomib+DAG pre-excitation regimen: Bortezomib (specification 3.5mg, intravenous injection, 4 times a course of treatment, 1.3mg/m2, d1, 4, 8, 11; doxorubicin liposome injection 5 mg/ m2, intravenous infusion, once every other day, 5 times in total; cytarabine 10 mg/m2 every 12 hours, subcutaneous injection, d1-14; G-CSF 200 μg/m2 daily, subcutaneous injection, d1-14 Days, WBC >10×109/L during chemotherapy, postpone the use until it falls below this value; | Drug | Control group: induction regimen B, Test group: Induction treatment plan A |
Primary outcome
Rate Rate of bone marrow blasts
Time frame: Evaluation at the 4th weekend after the end of all chemotherapy cycles
Bone marrow blasts <20%
5 secondary outcomes
blood routine
Time frame: Evaluation at the 4th weekend after the end of all chemotherapy cycles
liver function
Time frame: Evaluation at the 4th weekend after the end of all chemotherapy cycles
Recovery time
Time frame: Evaluation at the 4th weekend after the end of all chemotherapy cycles
The incidence of complications in patients
Time frame: Evaluation at the 4th weekend after the end of all chemotherapy cycles
kidney function
Time frame: Evaluation at the 4th weekend after the end of all chemotherapy cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
Related trials for Bortezomib
RecruitingPhase 1/2
PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCT
GVHD - Graft-Versus-Host Disease
RecruitingPhase 3
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Multiple Myeloma
RecruitingPhase 2
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
Plasma Cell Leukemia
Active, not recruitingPhase 3
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
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.
Fuling Zhou, phD study director
Wuhan University
TIANZHI WU, phD principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DAG pre-excitation regimen with Bortezomib in people with Bortezomib and Acute Myeloid Leukemia, run by Zhongnan 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 7 inclusion and 8 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 9 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Fuling Zhou, phD (+86-27-67811840, zhoufuling@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate Rate of bone marrow blasts (time frame: Evaluation at the 4th weekend after the end of all chemotherapy cycles). 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 9 Aug 2023.