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New treatment option for Relapsed or Refractory Acute Myeloid Leukemia
Official title A Single-arm, Prospective Study of TBI + BUMEL As a Conditioning Regimen for Salvage HSCT in Patients with R/R AML
ClinicalTrials.gov ID: NCT06879847
What this study is testing
- What it's testing
- Acute myeloid leukemia (AML) is one of the hematologic malignancies, for which patients typically undergo chemotherapy to achieve complete remission. However, approximately 30% of patients fail to respond to initial treatment, and many experience relapse after achieving remission.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 70
You may be able to join if
- Age between 14 and 70 years (inclusive of the age limits);
- Patients diagnosed with relapsed/refractory (R/R) AML, meeting the World Health Organization (WHO) 2016 AML diagnostic criteria, must meet one of the...
- Heart, liver, and kidney function must meet the following criteria: Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3× the...
- Availability of a suitable allogeneic donor;
- Life expectancy of ≥3 months;
You likely can't join if
- Patients had serious adverse reactions to investigational drugs such as allergies;
- Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ...
- Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or...
- Patients received Class II or higher surgery within 4 weeks prior to enrollment;
- Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require...
- Patient has active central nervous system leukemia infiltration;
See the full eligibility criteria
- Age between 14 and 70 years (inclusive of the age limits);
- Patients diagnosed with relapsed/refractory (R/R) AML, meeting the World Health Organization (WHO) 2016 AML diagnostic criteria, must meet one of the following definitions: Relapsed AML: Leukemic cells reappear in...
- Heart, liver, and kidney function must meet the following criteria: Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3× the upper limit of normal (ULN); Total bilirubin ≤ 3× ULN; Serum creatinine ≤...
- Availability of a suitable allogeneic donor;
- Life expectancy of ≥3 months;
- Karnofsky Performance Status (KPS) ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- The patient understands the study protocol and voluntarily signs the informed consent form.
- Patients had serious adverse reactions to investigational drugs such as allergies;
- Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;
- Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;
- Patients received Class II or higher surgery within 4 weeks prior to enrollment;
- Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C;
- Patient has active central nervous system leukemia infiltration;
- Pregnant or lactating patients;
- Patient is currently participating in another clinical studies;
- Other conditions where the investigator deems the patient unsuitable for inclusion.
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, 14 years to 70 years. 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.