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Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.

ConditionsAcute Myeloid Leukemia (AML)Relapse
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML.

At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old and ≤70 years old, male or female;

Patients with haploid peripheral blood stem cell transplantation of AML;

All patients received BU based myeloablative conditionings;

Blood routine: neutrophils ≥1×10^9/L, platelet ≥50.0×10^9/L;

Disqualifiers

Those who are allergic to known azacitidine or interferon

Patients with active acute GVHD;

Patients with moderate or more chronic GVHD;

Non-haploid donor transplants;

Trial design

Design model

Single group

Treatments tested in this trial

  • Azacitidine (AZA)

    Drug

    Azacitidine 32mg/m2

Treatment groups

51 Participants
are divided into 1 treatment group
Group A: AZA-DLI for acute myeloid leukemia post-transplant relapse preventiontExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Leukemia-free survival (LFS) time

Summary statistics for LFS time will be computed for all patients.

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.

Secondary outcomes

1

overall survival (OS)

The method of Kaplan and Meier will be used to estimate the distribution of overall survival. Cox proportional hazards regression analysis will be used to model the association between overall survival and covariates of interest.

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.
2

Cumulative incidence of relapse (CIR)

Use the method of Gooley et al to estimate the cumulative incidence of relapse.

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.
3

Cumulative incidence of acute and chronic GVHD

Patients diagnosed with acute and chronic GVHD were recorded after DLI intervention.The definition of acute GVHD by national Institutes of Health (NIH) divides acute GVHD into classical acute GVHD and delayed acute GVHD

Time frame
From the date of transplantation, assessed up to 1 year after transplantation.
4

NRM

The proportion of transplant-related deaths was recorded.

Time frame
NRM

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: