AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2VIDAZA-DLINCT01541280

VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

A Phase 2 study testing Azacitidine and DLI in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Azacitidine and DLI
Type of treatment
Injection or infusion
How many people
30 participants
Where
1 siteFrance
Study dates
Nov 2011to Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with high risk acute myeloid leukemia undergoing allogeneic transplantation with either a familial or an unrelated donor.
  • High risk AML is defined as :
  • AML in CR1 with unfavorable cytogenetics defined by complex caryotype, autosomal monosomy combined or not with other cytogenetics abnormalities inv(3)/t(3,3), t(6;9), t(6;11), t(11;19), del(5q), del(7q).
  • AML in CR2 or greater remission prior allogeneic transplantation
  • AML in PR or relapse prior allogeneic transplantation
  • Or Patients with high risk myelodysplastic syndrome undergoing allogeneic transplantation with either a familial or an unrelated donor.
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  • High risk MDS is defined as :
  • MDS with intermediate-2 group and higher risk group according to IPSS criteria
  • Age 18 - 70 years.
  • Availability of an HLA identical family donor or unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch.
  • Conditioning regimen to allogeneic transplantation may be either myeloablative or reduced.
  • Be able to understand and sign informed consent.
  • Affiliation number to National Health Care System
  • Men and women of childbearing potential must use effective contraception during and up to 3 months after treatment.

Who cannot join

  • The presence of any one exclusion criteria renders the patient ineligible:
  • Patient in full relapse post-transplant (>20% blasts in the bone marrow) following allogeneic transplant
  • Documented leukemic infiltration of CNS/cerebrospinal fluid.
  • Karnofsky performance score below 60%.
  • Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease.
  • following allogeneic transplant
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  • Severe liver failure (bilirubin >30 μmoles/L, SGPT > 4 X upper limit of normal).
  • Hepatic malignancy in advanced stage.
  • Severe neurological or psychiatric disorders
  • Acute GVHD grade II-III. Patient with grade I GVHD may be included (see annex 1 for GHVD grade definition).
  • Active uncontrolled infection.
  • Denied informed consent.
  • Treatment with other investigational drugs following allogeneic transplantation.
  • No effective contraception
  • Lactating females
  • Pregnant woman

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital of Nantes

    Nantes, 44000

Other trials in France

About this study

Official title: Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion.

Being tested
Azacitidine, DLI
Keywords
Allogreffe, LAM , MDS, Azacitidine (VidazaÒ), Injection de lymphocytes de donneur (DLI)
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    Azacitidine (AZA) is to be administered every 28 days beginning day +56 to 100 posttransplant for one year provided the patients has a platelet count of >15 x 109/L without transfusion for at least 2 successive days, and an absolute neutrophil count of >1 x 109/L without growth factor for at least 2 successive days, and no acute GVHD greater than grade I and no clinical evidence of life-threatening infection. AZA is given 32 mg /m²/day subcutaneously for 5 days every 28 days (

  • DLIOther

    Donor lymphocyte infusion (DLI) is to be given from day +126 (week 18) in patients without immunosuppressive therapy for at least one month and following 3 cycles of AZA, and without clinical signs of GVHD, and without uncontrolled infection and without a recent history of >grade 2 acute GVHD. DLI are schedules every 8 weeks. There are 3 DLI scheduled.

    If first cycle of AZA is postponed beyond day 56 (maximum to Day 100), all subsequent cycles and DLI will be post poned too.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the cumulative incidence of relapse rate

    An A'Hern procedure will be used (cf. 11.1): If the number of patients not relapsed at two year will be 18 or more out of 24 patients, the null hypothesis will be rejected and the relapse rate will be considered acceptable.

    Measured: 2 years

Secondary outcomes (6)

  1. Evaluation of disease-free survival (DFS) at 2 years from transplantation

    Kaplan-Meier method

    Measured: 2 years

  2. Measure the overall survival rate at 2 years

    Kaplan-Meier method

    Measured: 2 years

  3. Cumulative incidence death from leukemia, and non relapse mortality (NRM)

    cumulative incidence function for disease free survival at 2 years from transplantation, GVHD, death from leukaemia and non-relapse mortality will be estimated (patients are at risk not only for relapse but can also be "removed" from possible relapse because of competing events such as death in remission (due to infection or GVHD)).

    Measured: 2 years

  4. Feasibility and safety of administrating maintenance azacitidine following allogenic transplantaton

    To evaluate toxicity induced by the azacitidine and DLI, different parameters will be studied:Cell Blood Count with differential, liver function tests, serum creatinine, BUN and total protein will be performed weekly from the time of initiation of azacitidine administration until completion of the last DLI. Performance Status,Acute GVHD,Bone marrow aspiration with evaluation of morphological response as well as chimerism from peripheral blood will be performed prior starting azacitidine, following 3 cycles of azacitidine and after the seventh cycle and twelfth cycle of azacitidine.

    Measured: 2 years

  5. Feasibility and safety of performing prophylactic donor lymphocytes infusion

    The relatedness of observed toxicity to DLI will be evaluated and documented:

    • Maximum toxicity with respect to mucositis, liver, kidney, lung, heart, neurological system according to CTC criteria (cf. appendices).
    • Infections (bacteremia, fungemia, invasive fungal infection, CMV reactivation and disease, other viral reactivation or infection).
    • Grade of acute and chronic GVHD (cf. appendices); GVHD is classified according to clinical symptoms, irrespective to the time interval to DLI.
    • Bone marrow aspiration, as well as chimerism in PB.

    Measured: 2 years

  6. Incidence and severity of acute and chronic graft-versus-host disease

    Symptoms related to GVHD should be reported within the GVHD section of the case reporting files. AE and SAE are documented in the patient's chart

    • on a daily basis, as long as the patient is on ward, and
    • on a weekly to two-monthly basis during outpatient follow up, depending on the frequency of outpatient visits on the respective patient.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541280
Sponsor's protocol ID
BRD/10/07-H
Acronym
VIDAZA-DLI
Status last verified
Feb 2016
First submitted
13 Dec 2011
Last updated
14 Sep 2026
Results posted
No

Publications

  • Guillaume T, Malard F, Magro L, Labopin M, Tabrizi R, Borel C, Chevallier P, Vigouroux S, Peterlin P, Garnier A, Rubio MT, Huynh A, Milpied N, Moreau P, Gaugler B, Yakoub-Agha I, Mohty M. Prospective phase II study of prophylactic low-dose azacitidine and donor lymphocyte infusions following allogeneic hematopoietic stem cell transplantation for high-risk acute myeloid leukemia and myelodysplastic syndrome. Bone Marrow Transplant. 2019 Nov;54(11):1815-1826. doi: 10.1038/s41409-019-0536-y. Epub 2019 May 14.

    PubMed 31089280

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine and DLI in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the cumulative incidence of relapse rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01541280, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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