Treatment for relapse of acute myeloid leukemia after stem cell transplant

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

This study is testing a new treatment combining chemotherapy and donor immune cells for people who have relapsed acute myeloid leukemia after a stem cell transplant to see if it helps them recover safely.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06447090 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of a treatment regimen combining VMAC (venetoclax, liposomal mitoxantrone, cytarabine, and cyclophosphamide) with donor lymphocyte infusion (DLI) for patients who have relapsed acute myeloid leukemia (AML) following allogeneic hematopoietic stem cell transplantation. The study includes 30 participants and aims to monitor the occurrence of serious infections, cardiac toxicity, and graft-versus-host disease (GVHD) during treatment. Patients will be evaluated for efficacy through blood tests and bone marrow examinations four weeks after DLI, with follow-up extending for two years to assess long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with confirmed relapsed AML after allogeneic stem cell transplantation.

Not a fit: Patients with secondary transplants or those who have had a history of tumors treated in the past three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed AML after stem cell transplantation.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating relapsed AML with innovative regimens.

Eligibility criteria

Inclusion Criteria:

1. Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
2. Age ≥18 years and ≤65 years old, regardless of gender;
3. Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
4. 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.

Exclusion Criteria:

Subjects who meet any of the following criteria shall not be enrolled in this study:

* 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);
* 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;
* 5\) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
* 6\) Active heart disease, definition One or more of the following:

  1. Long QTc syndrome or QTc interval \>480ms;
  2. Complete left bundle branch block, II or III degree atrioventricular block;
  3. Need for drug treatment or History of severe arrhythmia with clinical symptoms;
  4. New York Heart Association classification ≥ II;
  5. Left ventricular ejection fraction less than 50%;
  6. 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.
* 7\) Transplantation from an unrelated donor;
* 8\) Those deemed not suitable for enrollment by the researcher.

Where this trial is running

Tianjin, Tianjin Municipality

• Institute of Hematology & Blood Diseases Hospital, China — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xin Chen, Doctor — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Xin Chen, Doctor

Conditions Relapse Acute Myeloid Leukemia; Mitoxantrone liposome