Using TBI and Melphalan for Second Stem Cell Transplantation in Blood Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of total body irradiation (TBI) combined with melphalan as a conditioning regimen for patients with malignant hematological diseases undergoing a second allogeneic hematopoietic stem cell transplantation (SCT2). The focus is on optimizing treatment strategies, immune regulation, complication management, and transplantation techniques to improve outcomes for patients who have experienced relapse or graft failure after their first transplant. By addressing these challenges, the study aims to enhance the overall survival rates and quality of life for these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Gender is not limited, patients between 14 to 70 years old (including critical value);
2. 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 diagnostic criteria, after the first hematopoietic stem cell transplantation, due to various reasons (including but not limited to disease relapse or graft failure) have indications for a second hematopoietic stem cell transplantation;
3. 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 ≤ 3×ULN; (3) Serum creatinine ≤ 2×ULN or creatinine clearance ≥ 40mL/min; (4) Left ventricular ejection fraction (LVEF) as measured by echocardiography or multi-gated acquisition (MUGA) scan is within the normal range (\> 50%);
4. Having a suitable allogeneic hematopoietic stem cell donor;
5. Expected survival ≥3 months;
6. Karnofsky (KPS) score ≥60%, Eastern Tumor Cooperative group (ECOG) status ≤ 2;
7. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

1. Patients had serious adverse reactions to investigational drugs such as allergies;
2. Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;
3. 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;
4. Received Class II or higher surgery within 4 weeks prior to enrollment;
5. Patients with active viral infections;
6. Pregnant or lactating patients;
7. The patient is currently participating in another clinical studies;
8. Patients deemed unsuitable for inclusion by other investigators.

Where it's running

• Hematology Department, The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Depei Wu, Prof. — The First Affiliated Hospital of Soochow University
• Study coordinator: Xiaojin Wu, Prof.
• Email: wuxiaojin@suda.edu.cn
• Phone: 13057493105

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.