Efficacy and Safety of VAH as a Bridging Regimen to Allo-HCT in Relapsed/Refractory AML
ConditionRelapse Leukemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-70
SponsorRuijin Hospital
About this trial
Allogeneic hematopoietic cell transplantation (allo-HCT) is the only treatment that offers a possible cure for relapsed/refractory AML. Currently, the optimal preallo-HCT bridging regimen for relapsed/refractory AML patients is unclear. Venetoclax-based regimens, including Venetoclax + demethylating agents (HMA) , Venetoclax + HMA + other drugs and Venetoclax-based multidrug combinations as a bridging regimen improves response rate and post-transplant survival in relapsed/refractory AML patients. Therefore, the investigators conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a transplant bridging regimen for relapsed/refractory AML.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 14 to 70 years (inclusive), regardless of gender;
The diagnosis of AML was confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests;
Relapsed AML: After achieving complete remission (CR), the reappearance of leukemic cells in peripheral blood, or ≥5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration by leukemic cells.
With RUNX1::RUNX1T1 AML: Positive measurable residual disease (MRD) on bone marrow flow evaluation after the second consolidation therapy and/or less than a 3-log decrease in the RUNX1::RUNX1T1 fusion gene and diagnostic baseline values;
Disqualifiers
Allergies or contraindications to any of the drugs in the protocol;
Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;
Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);
Active autoimmune diseases such as SLE, rheumatoid arthritis, etc;
Trial design
Design model
Single group
Treatments tested in this trial
VAH
DrugFor R/R AML patients, VAH bridging to conditioning regimen for allo-HCT.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year post-transplant relapse rate
relapse
Time frame
through study completion, an average of 2 yearSecondary outcomes
1
2-year event-free survival after transplantation
MRD positivity, relapse, death
Time frame
through study completion, an average of 2 year2
Overall survival at 2 years after transplantation
survival
Time frame
through study completion, an average of 2 yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: