Relapse Acute Myeloid LeukemiaPhase 2VMAC+DLINCT06447090
VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT
A Phase 2 study testing Mitoxantrone hydrochloride liposome in people with Relapse Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapse Acute Myeloid Leukemia
- What is being tested?
- Mitoxantrone hydrochloride liposome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2024to 31 Oct 2027
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
- Age ≥18 years and ≤65 years old, regardless of gender;
- Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
- An informed consent form must be signed before the start of the research procedure, and the patient himself or his immediate family members must sign the informed consent form. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member will sign the informed consent form.
Who cannot join
- Subjects who meet any of the following criteria shall not be enrolled in this study:
- 1) Secondary transplant patients;
- 2) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer , basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN);
- 3) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
- 4) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
- 5) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
Show all 15Show fewer
- 6) Active heart disease, definition One or more of the following:
- Long QTc syndrome or QTc interval >480ms;
- Complete left bundle branch block, II or III degree atrioventricular block;
- Need for drug treatment or History of severe arrhythmia with clinical symptoms;
- New York Heart Association classification ≥ II;
- Left ventricular ejection fraction less than 50%;
- Myocardial infarction, unstable angina, severe myocardial infarction within 6 months before enrollment History of unstable ventricular arrhythmias or any other arrhythmias requiring treatment, clinically severe pericardial disease, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- 7) Transplantation from an unrelated donor;
- 8) Those deemed not suitable for enrollment by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, 300000
Xin Chen, Doctor, 13920985705, chenxin@ihcams.ac.cn
About this study
Official title: Study on the Efficacy and Safety of VMAC Combined With Donor Lymphocyte Infusion (DLI) in the Treatment of Patients With Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation.
The main questions it aims to answer are:
The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;
Read the detailed description
venetoclax 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; liposomal mitoxantrone 30 mg/m2/d, d1; cytarabine (Ara-C) 100 mg/m2/d, d1-7; cyclophosphamide (CY) 400 mg/m2/d, d2, 5)，and then rest for 1 day before giving cryopreserved donor stem cells.MNC1-2X10^8/kg infusion, low-dose (25 mg Bid), short-course treatment (2-3 weeks after DLI) oral cyclosporine (CSA) is added to prevent graft-versus-host disease starting 3 days before the infusion of cryopreserved stem cells.
Monitor the occurrence of serious infections, cardiac toxicity, GVHD and other adverse reactions during the medication process; Blood routine recovery or bone marrow re examination 4 weeks after DLI to evaluate the efficacy of one course of VMAC combined with DLI; The patient was followed up for 2 years to evaluate long-term efficacy.
- Conditions
- Relapse Acute Myeloid Leukemia
- Being tested
- Mitoxantrone hydrochloride liposome
- Keywords
- Mitoxantrone liposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone hydrochloride liposomeDrug
Also called Venetoclax, Cytarabine,Cytosine arabinoside, Cyclophosphamide
Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| VMAC+DLI | Experimental | VMAC regimen :
Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion. Receives: Drug: Mitoxantrone hydrochloride liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRR
All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks
Measured: 1 year
Secondary outcomes (4)
PR
The maximum sum of diameters of tumor lesions decrease≥ 30% and is maintained for at least 4 weeks
Measured: 1 year
ORR
CR+PR
Measured: 1year
2-year OS
The time from the start of treatment to death due to any reason
Measured: 2 years
DFS
The time from the start of treatment to disease recurrence or death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start12 Apr 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Doctor, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447090
- Sponsor's protocol ID
- IIT2024002
- Acronym
- VMAC+DLI
- Status last verified
- May 2024
- First submitted
- 3 Jun 2024
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of VMAC Combined With Donor Lymphocyte Infusion (DLI) in the Treatment of Patients With Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06447090
- Acronym / sponsor ID
- VMAC+DLI / IIT2024002
- Conditions
- Relapse Acute Myeloid Leukemia
- Keywords
- Mitoxantrone liposome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 6 Jun 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.
This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation.
The main questions it aims to answer are:
The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;
Detailed description
venetoclax 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; liposomal mitoxantrone 30 mg/m2/d, d1; cytarabine (Ara-C) 100 mg/m2/d, d1-7; cyclophosphamide (CY) 400 mg/m2/d, d2, 5)，and then rest for 1 day before giving cryopreserved donor stem cells.MNC1-2X10^8/kg infusion, low-dose (25 mg Bid), short-course treatment (2-3 weeks after DLI) oral cyclosporine (CSA) is added to prevent graft-versus-host disease starting 3 days before the infusion of cryopreserved stem cells.
Monitor the occurrence of serious infections, cardiac toxicity, GVHD and other adverse reactions during the medication process; Blood routine recovery or bone marrow re examination 4 weeks after DLI to evaluate the efficacy of one course of VMAC combined with DLI; The patient was followed up for 2 years to evaluate long-term efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VMAC+DLI | Experimental | Drug: Mitoxantrone hydrochloride liposomeVMAC regimen : Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
- Age ≥18 years and ≤65 years old, regardless of gender;
- Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
- An informed consent form must be signed before the start of the research procedure, and the patient himself or his immediate family members must sign the informed consent form. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member will sign the informed consent form.
Key exclusion criteria (15 listed)
- 1) Secondary transplant patients;
- 2) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer , basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN);
- 3) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
- 4) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
- 5) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
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 |
|---|---|---|
| Mitoxantrone hydrochloride liposomeAlso: Venetoclax, Cytarabine,Cytosine arabinoside, CyclophosphamideVeneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion. | Drug | VMAC+DLI |
Primary outcome
CRR
Time frame: 1 year
All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks
4 secondary outcomes
PR
Time frame: 1 year
ORR
Time frame: 1year
2-year OS
Time frame: 2 years
DFS
Time frame: 2 years
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 6 Jun 2024.
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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.
Xin Chen, Doctor principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone hydrochloride liposome in people with Relapse Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 15 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 6 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xin Chen, Doctor (13920985705, chenxin@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRR (time frame: 1 year). 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 6 Jun 2024.