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New treatment option for Malignant Hematological Diseases
Official title A Single-Arm, Prospective Study of TBI+BUMEL as Conditioning for SCT2 in Patients With Malignant Hematologic Diseases
ClinicalTrials.gov ID: NCT06548958
What this study is testing
- What it's testing
- Each year, over 20,000 patients in China undergo hematopoietic stem cell transplantation (HSCT). Unfortunately, the prognosis in patients with disease relapse or graft failure is often inferior.
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
- Gender is not limited, patients between 14 to 70 years old (including critical value);
- Malignant hematological diseases (acute/chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, malignant lymphoma, etc.)...
- The indexes of cardiac function, liver and kidney function were within the following limits: (1) Alanine aminotransferase (ALT) and aspartate...
- Having a suitable allogeneic hematopoietic stem cell donor;
- Expected survival ≥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...
- Received Class II or higher surgery within 4 weeks prior to enrollment;
- Patients with active viral infections;
- Pregnant or lactating patients;
See the full eligibility criteria
- Gender is not limited, patients between 14 to 70 years old (including critical value);
- Malignant hematological diseases (acute/chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, malignant lymphoma, etc.) diagnosed by bone marrow aspiration or biopsy according to the WHO...
- The indexes of cardiac function, liver and kidney function were within the following limits: (1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× Upper limit of normal (ULN); (2)Total bilirubin ≤...
- Having a suitable allogeneic hematopoietic stem cell donor;
- Expected survival ≥3 months;
- Karnofsky (KPS) score ≥60%, Eastern Tumor Cooperative group (ECOG) status ≤ 2;
- Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.
- 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;
- Received Class II or higher surgery within 4 weeks prior to enrollment;
- Patients with active viral infections;
- Pregnant or lactating patients;
- The patient is currently participating in another clinical studies;
- Patients deemed unsuitable for inclusion by other investigators.
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.