Recurrent Adult Acute Myeloid LeukemiaNCT06329999
A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML
A study testing CMGV in people with Recurrent Adult Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Adult Acute Myeloid Leukemia, Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia
- What is being tested?
- CMGV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2024to 31 Dec 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
- Age: 18-75 years old (including boundary values of 18 and 75);
- Clinically confirmed adult AML and MDS-IB2 (WHO 2022 standard) patients, AML patients meet any of the following criteria:
- Treatment related AML
- Previously had a history of MDS
- Associated with MDS related genes/chromosomal abnormalities
Show all 13Show fewer
- Previously had a history of CMML
- Age ≥ 60 years old
- Previous history of prodromal MPN, including ET, PV, and MF, with bone marrow fibrosis ≤ grade 2 (according to the 0-3 grade standard)；
- For elderly AML or MDS patients, the comprehensive evaluation should be based on the Fit population: ECOG<3, no major comorbidities, and MMSE and SPPB meet the standards (refer to Appendix 8-11);
- Expected survival time ≥ 3 months;
- Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal value (ULN) (≤ 5 times the upper limit of normal value for patients with liver infiltration); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver infiltration); Serum creatinine ≤ 1.5 times the upper limit of normal value;
- The relevant treatment for MDS (excluding blood transfusion) must be completed 2 weeks before the start of the study treatment; In the case of rapidly proliferative diseases, hydroxyurea is allowed to be used until 24 hours before the start of the study treatment. Before starting the research treatment,Toxicity related to previous MDS treatment must be restored to level 2 or below.
Who cannot join
- The researchers determined that patients who are not suitable to participate in this study. If a patient meets any of the following criteria, they will not be allowed to enter this study:
- The subject's previous history of anti-tumor treatment meets one of the following conditions:
- Individuals who have previously received mitoxantrone or mitoxantrone liposomes;
- Previously received treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin>360mg/m2 (1mg of doxorubicin is equivalent to 2mg of doxorubicin or 0.5mg of doxorubicin);
- Within 4 weeks prior to the first use of the study drug or within 5 half-lives of the drug, the patient has received anti-tumor treatment including surgery, chemotherapy, targeted therapy, or participated in other clinical trials and received clinical trial medication;
- Heart function and disease meet one of the following conditions:
Show all 23Show fewer
- Long QTc syndrome or QTc interval>480ms;
- Complete left bundle branch block, II or III degree atrioventricular block;
- Severe and uncontrolled arrhythmias that require medication treatment;
- The New York College of Cardiology in the United States has a classification of ≥ II;
- Cardiac ejection fraction (LVEF) below 50%;
- A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to recruitment.
- Patients who have previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated for more than 6 months and have been effectively controlled, as well as patients who have received long-term non chemotherapy treatments such as hormone therapy);
- Uncontrollable systemic diseases (such as infection during the promotion period, uncontrollable hypertension, diabetes, etc.);
- Central nervous system leukemia;
- Secondary AML patients with bone marrow fibrosis ≥ grade 3;
- CML patients with sudden changes;
- Accompanied by a well prognosis chromosome karyotype t (8; 21) (q22; q22.1) RUNX1:: RUNX1T1, inv (16) (p13.1 q22) CBFB: MYH11, as well as acute promyelocytic leukemia;
- Human immunodeficiency virus (HIV) infected individuals (HIV antibody positive);
- Active infection of hepatitis B and hepatitis C (if hepatitis B B surface antigen or core antibody is positive, HBV-DNA will be tested additionally, and if HBV-DNA exceeds 1x103 copies/mL, it will be excluded; if hepatitis C antibody is positive, HCV-RNA will be tested additionally, and if hepatitis C virus RNA exceeds 1x103 copies/mL, it will be excluded);
- Have a known history of immediate or delayed hypersensitivity reactions to similar drugs and excipients in the study drug;
- Accompanied by a history of severe neurological or mental illness;
- The researchers determined that there were patients who were not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
sujiang Zhang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality
xiaoqian Xu, Doctor, 13816205940, Ellenxxq@qq.com
About this study
Official title: A Prospective, Multicenter, and Exploratory Study of Mitoxantrone Liposomes, Cytarabine and G-CSF Combined With Vineclavone in the Treatment ofRecurrent Adult AML and MDS-EB-2/Elder AML
The goal of this clinical trial] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia]. The main questions it aims to answer are:
- Evaluation of the efficacy
- Evaluation of the safety
Read the detailed description
Mitoxantrone is a traditional anthracycline drug. It exerts anti-tumor effects by interfering with DNA, RNA and inhibiting topoisomerase II. It is a cell cycle non-specific drug ; Mitoxantrone has been used in AML patients. It is widely used in both induction and relapse and refractory treatment stages . At the same time, the literature shows that there is no complete cross-resistance between mitoxantrone and other anthracycline drugs, and it is still effective for patients who have relapsed after previous first-line anthracycline treatment . In addition, the CMG (standard dose cytarabine + mitoxantrone + G-CSF) prestimulation regimen has many applications in China ; a study showed that 16 cases of elderly AML (50% were early in the elderly The CR rate of the CMG regimen for the treatment of secondary AML was 50%, the ORR was 87.4%, and the median OS was 12 months in 2006; a study applied the CMG regimen vs. the conventional dose MA regimen (mitoxantrone + arabinoside Glucoside) in the treatment of elderly AML, the results showed that there was no significant difference in efficacy between the two regimens, but the CMG group had a shorter bone marrow suppression period and less bleeding and infection than the MA group in 2014. Since there is no drug for mitoxantrone in the domestic market for a long period of time, its clinical application is limited. Mitoxantrone Hydrochloride Liposomal Injection is a Class 2 new drug independently developed by CSPC. It will be launched in China in 2022. The approved indications are: those who have received at least first-line standard treatment (including chemotherapy, autologous hematopoietic stem cell transplantation, etc.) For patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), the registration key phase II clinical trial showed good therapeutic effects in relapsed or refractory PTCL and NKTCL, with a confirmed ORR of 41.7%; among them, NKTCL subtype The type has remarkable efficacy, breaking through the limitations of NKTCL's natural resistance to anthracyclines in previous clinical experience. The ORR of single-drug treatment can reach 42.9%.
- Conditions
- Recurrent Adult Acute Myeloid Leukemia, Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia
- Being tested
- CMGV
- Keywords
- Mitoxantrone Hydrochloride Liposomes, Cytarabine, Venetoclax, Recurrent Adult Acute Myeloid Leukemia, MDS-EB-2, Adult Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMGVDrug
Also called CMGV REGIME
Initial treatment induction therapy: CMG+Vineclavone regimen Mitoxantrone liposomes 15mg/m2, iv, d1; Cytarabine 10mg/m2, H, q12h, d1-7; G-CSF starts at 5ug/kg, H, d0, WBC ≥ 30 × 109/L, stop G-CSF; Vinecla 100mg, 2200mg, 3400mg, d4-10. Every 4 weeks is a cycle, for a total of 2 cycles. For patients with CR/CRI/MLFS/PR in the first cycle, repeat this regimen for consolidation treatment once (the second course of treatment is Vineclavone 400mg d1-7).
Follow up treatment: Patients who meet the transplantation criteria will undergo hematopoietic stem cell transplantation, while those who do not undergo transplantation will continue to receive CMG+Vineclavone consolidation for 4-6 courses.
| Study group | Role | What they receive |
|---|---|---|
| CMGV regime | Experimental | Mitoxantrone liposomes，Cytarabine，G-CSF，Venetoclax Receives: Drug: CMGV |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRc
CR (complete remission)+CRi (CR with incomplete recovery of hematological counts)
Measured: 1year
Secondary outcomes (5)
ORR
Objective Response Rate
Measured: 1 year
OS
Overall Survival
Measured: 2 year
RFS
Relapse-free survival
Measured: 2 year
MRD-
Assessable residual lesion (MRD) conversion rate to negative
Measured: 1 year
Adverse Event
Hematological and non hematological toxicit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start3 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Ruijin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital, Army Medical Center of PLA, Sun Yat-sen University, RenJi Hospital, Shanghai Jiading District Central Hospital, The Second Affiliated Hospital of Dalian Medical University, First Hospital of China Medical University, Dalian Municipal Central Hospital, Shanghai Zhongshan Hospital, Shanghai Pudong Hospital, Shanghai Public Health Clinical Center, Xuhui Central Hospital, Shanghai, The Affiliated People's Hospital of Ningbo University, Taizhou First People's Hospital, Wenzhou People's Hospital
- Responsible party
- Sponsor
- Investigators
- sujiang Zhang, Doctor, Principal investigator, Hematological Depaement, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329999
- Sponsor's protocol ID
- CMG-sAML-001
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, and Exploratory Study of Mitoxantrone Liposomes, Cytarabine and G-CSF Combined With Vineclavone in the Treatment ofRecurrent Adult AML and MDS-EB-2/Elder AML
- ClinicalTrials.gov ID
- NCT06329999
- Acronym / sponsor ID
- CMG-sAML-001
- Conditions
- Recurrent Adult Acute Myeloid Leukemia, Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia
- Keywords
- Mitoxantrone Hydrochloride Liposomes, Cytarabine, Venetoclax, Recurrent Adult Acute Myeloid Leukemia, MDS-EB-2, Adult Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Huadong Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital, Army Medical Center of PLA, Sun Yat-sen University, RenJi Hospital, Shanghai Jiading District Central Hospital, The Second Affiliated Hospital of Dalian Medical University, First Hospital of China Medical University, Dalian Municipal Central Hospital, Shanghai Zhongshan Hospital, Shanghai Pudong Hospital, Shanghai Public Health Clinical Center, Xuhui Central Hospital, Shanghai, The Affiliated People's Hospital of Ningbo University, Taizhou First People's Hospital, Wenzhou People's Hospital
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Mar 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.
The goal of this clinical trial] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia]. The main questions it aims to answer are:
- Evaluation of the efficacy
- Evaluation of the safety
Detailed description
Mitoxantrone is a traditional anthracycline drug. It exerts anti-tumor effects by interfering with DNA, RNA and inhibiting topoisomerase II. It is a cell cycle non-specific drug ; Mitoxantrone has been used in AML patients. It is widely used in both induction and relapse and refractory treatment stages . At the same time, the literature shows that there is no complete cross-resistance between mitoxantrone and other anthracycline drugs, and it is still effective for patients who have relapsed after previous first-line anthracycline treatment . In addition, the CMG (standard dose cytarabine + mitoxantrone + G-CSF) prestimulation regimen has many applications in China ; a study showed that 16 cases of elderly AML (50% were early in the elderly The CR rate of the CMG regimen for the treatment of secondary AML was 50%, the ORR was 87.4%, and the median OS was 12 months in 2006; a study applied the CMG regimen vs. the conventional dose MA regimen (mitoxantrone + arabinoside Glucoside) in the treatment of elderly AML, the results showed that there was no significant difference in efficacy between the two regimens, but the CMG group had a shorter bone marrow suppression period and less bleeding and infection than the MA group in 2014. Since there is no drug for mitoxantrone in the domestic market for a long period of time, its clinical application is limited. Mitoxantrone Hydrochloride Liposomal Injection is a Class 2 new drug independently developed by CSPC. It will be launched in China in 2022. The approved indications are: those who have received at least first-line standard treatment (including chemotherapy, autologous hematopoietic stem cell transplantation, etc.) For patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), the registration key phase II clinical trial showed good therapeutic effects in relapsed or refractory PTCL and NKTCL, with a confirmed ORR of 41.7%; among them, NKTCL subtype The type has remarkable efficacy, breaking through the limitations of NKTCL's natural resistance to anthracyclines in previous clinical experience. The ORR of single-drug treatment can reach 42.9%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMGV regime | Experimental | Drug: CMGVMitoxantrone liposomes，Cytarabine，G-CSF，Venetoclax |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
- Age: 18-75 years old (including boundary values of 18 and 75);
- Clinically confirmed adult AML and MDS-IB2 (WHO 2022 standard) patients, AML patients meet any of the following criteria:
- For elderly AML or MDS patients, the comprehensive evaluation should be based on the Fit population: ECOG<3, no major comorbidities, and MMSE and SPPB meet the standards (refer to Appendix 8-11);
- Expected survival time ≥ 3 months;
Key exclusion criteria (23 listed)
- The researchers determined that patients who are not suitable to participate in this study. If a patient meets any of the following criteria, they will not be allowed to enter this study:
- The subject's previous history of anti-tumor treatment meets one of the following conditions:
- Heart function and disease meet one of the following conditions:
- Patients who have previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated for more than 6 months and have been effectively controlled, as well as patients who have received long-term non chemotherapy treatments such as hormone therapy);
- Uncontrollable systemic diseases (such as infection during the promotion period, uncontrollable hypertension, diabetes, etc.);
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 |
|---|---|---|
| CMGVAlso: CMGV REGIMEInitial treatment induction therapy: CMG+Vineclavone regimen Mitoxantrone liposomes 15mg/m2, iv, d1; Cytarabine 10mg/m2, H, q12h, d1-7; G-CSF starts at 5ug/kg, H, d0, WBC ≥ 30 × 109/L, stop G-CSF; Vinecla 100mg, 2200mg, 3400mg, d4-10. Every 4 weeks is a cycle, for a total of 2 cycles. For patients with CR/CRI/MLFS/PR in the first cycle, repeat this regimen for consolidation treatment once (the second course of treatment is Vineclavone 400mg d1-7). Follow up treatment: Patients who meet the transplantation criteria will undergo hematopoietic stem cell transplantation, while those who do not undergo transplantation will continue to receive CMG+Vineclavone consolidation for 4-6 courses. | Drug | CMGV regime |
Primary outcome
CRc
Time frame: 1year
CR (complete remission)+CRi (CR with incomplete recovery of hematological counts)
5 secondary outcomes
ORR
Time frame: 1 year
OS
Time frame: 2 year
RFS
Time frame: 2 year
MRD-
Time frame: 1 year
Adverse Event
Time frame: 1 year
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 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Recurrent Adult Acute Myeloid Leukemia
Not yet recruitingPhase 1
A Study of CLEC2A CAR T for Pediatric and Adult Patients With Relapsed or Refractory AML
Acute Myeloid Leukemia, Acute Myeloid Leukaemia Recurrent
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
RecruitingPhase 1
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
AML (Acute Myelogenous Leukemia, Relapsed Acute Myelogenous Leukemia
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.
sujiang Zhang, Doctor contact
sujiang Zhang, Doctor principal investigator
Hematological Depaement, Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMGV in people with Recurrent Adult Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Ruijin 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 13 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 26 Mar 2024. 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?
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 Xiaoqian Xu, Doctor (13816205940, Ellenxxq@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRc (time frame: 1year). 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 Mar 2024.