Status:
NOT_YET_RECRUITING
Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Graft-versus-host Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and ...
Detailed Description
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and ...
Eligibility Criteria
Inclusion
- Subjects eligible for inclusion in this study must meet all of the following criteria:
- Patients with malignant hematological diseases undergo haploid/sibling incomplete matching/unrelated donor transplantation;
- Recurrence after transplantation (morphological, extramedullary, or molecular recurrence);
- Plan to administer granulocyte colony-stimulating factor mobilization donor lymphocyte infusion (gDLI) for treatment;
- No age, gender, or race restrictions;
- The physical condition assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
- The patient or their authorized representative agrees to participate in the clinical trial and signs an informed consent form.
Exclusion
- Subjects meeting any of the following criteria are not eligible for inclusion in this study:
- Siblings of matched donor transplant;
- Patients with other malignant tumors that require treatment;
- There are active infections, such as hepatitis B, hepatitis C, tuberculosis, etc;
- HIV serological reaction was positive;
- Suffering from mental illness or other conditions that cannot comply with research, treatment, and monitoring requirements;
- Pregnant patients or patients who are unable to take appropriate contraceptive measures during treatment;
- Active heart disease is defined as one or more of the following:
- Have a history of uncontrolled or symptomatic angina pectoris;
- Myocardial infarction less than 6 months prior to enrollment in the study;
- A history of arrhythmia requiring medication treatment or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\>NYHA level 2);
- The ejection fraction is below the lower limit of the normal range.
- Individuals who are allergic to any medication or component such as Cy, CNI, etc;
- The researchers believe that it is not suitable for participants.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06490562
Start Date
July 1 2024
End Date
December 1 2028
Last Update
July 8 2024
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