Relapse LeukemiaNCT06385808
Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML
A study testing MTBF regimen in people with Relapse Leukemia and Refractory Acute Myeloid Leukemia, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapse Leukemia, Refractory Acute Myeloid Leukemia, Conditioning
- What is being tested?
- MTBF regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up;
- Age 18-65 years old (including upper and lower limits);
- No gender limitation
- Relapsed or refractory (R/R) acute myeloid leukemia can not achieve complete remission by chemotherapy, and has the indication of salvage allogeneic hematopoietic stem cell transplantation.
- R/R AML was defined as: ① Initial treatment cases that failed after 2 courses of standard chemotherapy; ② After CR consolidation and intensive treatment, relapse within 12 months; ③ Recurred 12 months later, but conventional chemotherapy was ineffective; ④ Two or more relapses; ⑤ Extramedullary leukemia persists; ⑥Leukemia cells in peripheral blood or the proportion of bone marrow original cells >0.050 or the occurrence of extramedullary leukemia cell infiltration after CR.
- Could tolerate allogeneic hematopoietic stem cell transplantation.
Who cannot join
- Hypersensitivity to any investigational drug or its components;
- Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.)
- Cardiac function and disease meet one of the following conditions:
- Long QTc syndrome or QTc interval>480 ms;
- Complete left bundle branch block, II or III degree atrioventricular block;
- Serious and uncontrolled arrhythmia requiring drug treatment;
Show all 15Show fewer
- American New York Heart Association rating ≥ III degree;
- Cardiac ejection fraction (LVEF) is less than 60%;
- History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or He has any arrhythmia requiring treatment, clinical history of serious pericardial disease, or acute ischemia or activity ECG evidence of abnormal conduction system;
- Active infection of hepatitis B and hepatitis C;
- Human immunodeficiency virus (HIV) infection;
- Patients with other malignant tumors;
- History of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or history of drug dependence (sedative hypnotics, analgesics, narcotics, stimulants and psychotropic drugs, etc.);
- History of mental illness or cognitive impairment;
- Other investigators determined that participation in this study was not appropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined With Thiotepa, Busulfan and Fludarabine Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed or Refractory Acute Myeloid Leukemia
The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.
Read the detailed description
High-intensity conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) can maximize the clearance of leukemia cells, but is often associated with increased pretreatment-related toxicity and transplant-related mortality. In order to enhance its anti-tumor effect without increasing or even decreasing its tissue toxicity, and then prolong the overall survival of AML patients, we optimized the conditioning regimen before allo-HSCT transplantation: (1) The classical Thiotepa/Busulfan/Fludarabine (TBF) regimen will be adopted to reduce the conditioning associated toxicity, ensure graft implantation to the maximum extent and reduce the recurrence rate; ② At the same time, mitoxantrone hydrochloride liposome will be added to avoid the disadvantages of weak immunosuppressive effect and weak anti-leukemia effect, and MTBF pretreatment scheme will be finally explored. It has been applied in the pre-treatment of salvage allo-HSCT in 3 patients with relapsed and refractory acute myeloid leukemia with good safety. Up to the present follow-up time of 4 months, all 3 patients have disease free survival. To evaluate the safety and efficacy of this protocol, we intend to include more patients undergoing salvage allo-HSCT for relapsed or refractory (R/R) AML.
- Conditions
- Relapse Leukemia, Refractory Acute Myeloid Leukemia, Conditioning, Hematopoietic Stem Cell Transplantation
- Being tested
- MTBF regimen
- Keywords
- relapsed or refractory acute myeloid leukemia, conditioning regimen, allogeneic hematopoietic stem cell transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTBF regimenDrug
Also called Mitoxantrone Hydrochloride Liposome, Thiotepa, Busulfan, Fludarabine
The subjects will be treated with mitoxantrone hydrochloride liposome combined with thiotepa, busulfan and fludarabine as conditioning regimen prior to allo-HSCT.
Mitoxantrone hydrochloride liposome 24mg/m^2 ivgtt d-7; Ctepide 5mg/kg ivgtt d-6~-5; Busulfan 0.8mg/kg q6h ivgtt d-4~-2; Fludarabine 50mg/m^2 ivgtt d-4~-2.
| Study group | Role | What they receive |
|---|---|---|
| MTBF regimen group | Experimental | The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. Receives: Drug: MTBF regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Disease activity in patients after transplantation
Measured: 2 years post transplantation
Secondary outcomes (5)
Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0)
The incidence and severity of non-hematological adverse events were evaluated using NCI CTCAE v5.0 criteria.
Measured: from the beginning of the conditioning regimen to 2 years post transplantation
Neutrophil recovery time
Peripheral blood neutrophil count (ANC) ≥0.5×10^9/L for three consecutive days without blood transfusion support
Measured: 1 month post transplantation
Platelet recovery time
Peripheral blood platelet (PLT) ≥20×10^9/L for three consecutive days without blood transfusion support.
Measured: 1 month post transplantation
OS
Overall survival
Measured: From date of diagnosis until the end of follow-up or the date of death from any couse. Time rage: 6 months post transplantation, 12 months post transplantation.
PFS
Progression-free survival
Measured: From date of diagnosis until the end of follow-up or disease progression. Time rage: 6 months post transplantation, 12 months post transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse LeukemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoning Wang, M.D., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385808
- Sponsor's protocol ID
- XJTU1AF-CRF-2023-XK014
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 26 Apr 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined With Thiotepa, Busulfan and Fludarabine Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06385808
- Acronym / sponsor ID
- XJTU1AF-CRF-2023-XK014
- Conditions
- Relapse Leukemia, Refractory Acute Myeloid Leukemia, Conditioning, Hematopoietic Stem Cell Transplantation
- Keywords
- relapsed or refractory acute myeloid leukemia, conditioning regimen, allogeneic hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Apr 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 primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.
Detailed description
High-intensity conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) can maximize the clearance of leukemia cells, but is often associated with increased pretreatment-related toxicity and transplant-related mortality. In order to enhance its anti-tumor effect without increasing or even decreasing its tissue toxicity, and then prolong the overall survival of AML patients, we optimized the conditioning regimen before allo-HSCT transplantation: (1) The classical Thiotepa/Busulfan/Fludarabine (TBF) regimen will be adopted to reduce the conditioning associated toxicity, ensure graft implantation to the maximum extent and reduce the recurrence rate; ② At the same time, mitoxantrone hydrochloride liposome will be added to avoid the disadvantages of weak immunosuppressive effect and weak anti-leukemia effect, and MTBF pretreatment scheme will be finally explored. It has been applied in the pre-treatment of salvage allo-HSCT in 3 patients with relapsed and refractory acute myeloid leukemia with good safety. Up to the present follow-up time of 4 months, all 3 patients have disease free survival. To evaluate the safety and efficacy of this protocol, we intend to include more patients undergoing salvage allo-HSCT for relapsed or refractory (R/R) AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied.
| Arm | Type | Receives |
|---|---|---|
| MTBF regimen group | Experimental | Drug: MTBF regimenThe relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up;
- Age 18-65 years old (including upper and lower limits);
- No gender limitation
- Relapsed or refractory (R/R) acute myeloid leukemia can not achieve complete remission by chemotherapy, and has the indication of salvage allogeneic hematopoietic stem cell transplantation.
- R/R AML was defined as: ① Initial treatment cases that failed after 2 courses of standard chemotherapy; ② After CR consolidation and intensive treatment, relapse within 12 months; ③ Recurred 12 months later, but conventional chemotherapy was ineffective; ④ Two or more relapses; ⑤ Extramedullary leukemia persists; ⑥Leukemia cells in peripheral blood or the proportion of bone marrow original cells >0.050 or the occurrence of extramedullary leukemia cell infiltration after CR.
Key exclusion criteria (15 listed)
- Hypersensitivity to any investigational drug or its components;
- Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.)
- Cardiac function and disease meet one of the following conditions:
- Active infection of hepatitis B and hepatitis C;
- Human immunodeficiency virus (HIV) infection;
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 |
|---|---|---|
| MTBF regimenAlso: Mitoxantrone Hydrochloride Liposome, Thiotepa, Busulfan, FludarabineThe subjects will be treated with mitoxantrone hydrochloride liposome combined with thiotepa, busulfan and fludarabine as conditioning regimen prior to allo-HSCT. Mitoxantrone hydrochloride liposome 24mg/m^2 ivgtt d-7; Ctepide 5mg/kg ivgtt d-6~-5; Busulfan 0.8mg/kg q6h ivgtt d-4~-2; Fludarabine 50mg/m^2 ivgtt d-4~-2. | Drug | MTBF regimen group |
Primary outcome
Recurrence rate
Time frame: 2 years post transplantation
Disease activity in patients after transplantation
5 secondary outcomes
Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0)
Time frame: from the beginning of the conditioning regimen to 2 years post transplantation
Neutrophil recovery time
Time frame: 1 month post transplantation
Platelet recovery time
Time frame: 1 month post transplantation
OS
Time frame: From date of diagnosis until the end of follow-up or the date of death from any couse. Time rage: 6 months post transplantation, 12 months post transplantation.
PFS
Time frame: From date of diagnosis until the end of follow-up or disease progression. Time rage: 6 months post transplantation, 12 months post transplantation.
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 Apr 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.
Xiaoning Wang, M.D. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A study testing MTBF regimen in people with Relapse Leukemia and Refractory Acute Myeloid Leukemia, run by First Affiliated Hospital Xi'an Jiaotong University.
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 6 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: opening soon, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaoning Wang, M.D. (0086-18991232608, wangxn99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 2 years post transplantation). 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 Apr 2024.