NCT06447090RecruitingPhase 2
VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT
Study on the Efficacy and Safety of VMAC Combined With Donor Lymphocyte Infusion (DLI) in the Treatment of Patients With Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
Source: ClinicalTrials.gov · Last updated 6 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation. The main questions it aims to answer are: The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Jun 2024
- Start date
- 12 Apr 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06447090
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 12 Apr 2024 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\) Secondary transplant patients;
- 2\) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer , basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN);
- 7\) Transplantation from an unrelated donor;
Other illness
- 3\) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
- 4\) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
Lab values
- 6\) Active heart disease, definition One or more of the following:
- Long QTc syndrome or QTc interval \>480ms;
- Complete left bundle branch block, II or III degree atrioventricular block;
- Need for drug treatment or History of severe arrhythmia with clinical symptoms;
- New York Heart Association classification ≥ II;
- Left ventricular ejection fraction less than 50%;
- Myocardial infarction, unstable angina, severe myocardial infarction within 6 months before enrollment History of unstable ventricular arrhythmias or any other arrhythmias requiring treatment, clinically severe pericardial disease, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Other
- Subjects who meet any of the following criteria shall not be enrolled in this study:
- 5\) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
- 8\) Those deemed not suitable for enrollment by the researcher.
Who the study is looking for
- Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
- Age ≥18 years and ≤65 years old, regardless of gender;
- Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
- An informed consent form must be signed before the start of the research procedure, and the patient himself or his immediate family members must sign the informed consent form. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member will sign the informed consent form.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, China Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.