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New treatment option for Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Official title VABu Conditioning in Elderly AML HSCT
ClinicalTrials.gov ID: NCT07583888
What this study is testing
What is VaBU?
VaBU is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for allogeneic hematopoietic stem cell transplantation recipient.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Age ≥ 60 years.
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.
- Previous response to Venetoclax-based therapy.
- Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).
- Donor availability: Related donor matched at least 5/10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8/10 at the same loci.
You likely can't join if
- Age \< 60 years.
- Poor response to prior Venetoclax-based therapy.
- Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe...
- Active uncontrolled infection or active bleeding in vital organs.
- CNS symptoms grade ≥ 2 requiring treatment.
- Major organ surgery within 6 weeks.
See the full eligibility criteria
- Age ≥ 60 years.
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.
- Previous response to Venetoclax-based therapy.
- Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).
- Donor availability: Related donor matched at least 5/10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8/10 at the same loci.
- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 4.
- ECOG performance status 0-2.
- Adequate organ function as defined by: Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 45 mL/min (Cockcroft-Gault formula or 24-hour urine collection)； AST ≤ 3.0 × ULN and ALT ≤ 3.0 × ULN； Total bilirubin ≤ 1.5 × ULN；...
- Ability to understand and provide written informed consent.
- Age \< 60 years.
- Poor response to prior Venetoclax-based therapy.
- Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension).
- Active uncontrolled infection or active bleeding in vital organs.
- CNS symptoms grade ≥ 2 requiring treatment.
- Major organ surgery within 6 weeks.
- History of malignant disease other than AML within 5 years.
- History of thrombosis, embolism, or cerebral hemorrhage within 1 year.
- ECOG performance status \> 2.
- HCT-CI score \> 4.
- Organ failure meeting specified criteria.
- Known HIV, active HBV, or active HCV infection.
- History of autoimmune disease requiring systemic immunosuppressive therapy.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception in patients of childbearing potential.
- Drug abuse or chronic alcoholism.
- Psychiatric disorder or other condition compromising informed consent or compliance.
- Any other condition making the patient unsuitable for study participation in the investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.