Evidence map›Paper›PMID 31089280›Full record

Trial reportBone marrow transplantation2019

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.

Thierry Guillaume, Florent Malard, Leonardo Magro, Myriam Labopin, Reza Tabrizi, Cécile Borel, Patrice Chevallier, Stéphane Vigouroux, Pierre Peterlin, Alice Garnier and 7 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Thierry GuillaumeHematology Department, Nantes University Hospital, Nantes, France. thierry.guillaume@chu-nantes.fr.
Florent MalardHematology Department, AP-HP, Saint-Antoine Hospital, Paris, France.ORCID http://orcid.org/0000-0002-3474-0002
Leonardo MagroBone Marrow Transplantation Unit, Lille University Hospital, Lille, France.
Myriam LabopinHematology Department, AP-HP, Saint-Antoine Hospital, Paris, France.
Reza TabriziHematology and Cell Therapy Department, Bordeaux University Hospital, Pessac, France.
Cécile BorelHematology Department, Institut Universitaire du Cancer Toulouse - Oncopole, Toulouse, France.
Patrice ChevallierHematology Department, Nantes University Hospital, Nantes, France.
Stéphane VigourouxHematology and Cell Therapy Department, Bordeaux University Hospital, Pessac, France.
Pierre PeterlinHematology Department, Nantes University Hospital, Nantes, France.
Alice GarnierHematology Department, Nantes University Hospital, Nantes, France.
Marie-Thérèse RubioHematology Department, AP-HP, Saint-Antoine Hospital, Paris, France.
Anne HuynhHematology Department, Institut Universitaire du Cancer Toulouse - Oncopole, Toulouse, France.
Noël MilpiedHematology and Cell Therapy Department, Bordeaux University Hospital, Pessac, France.
Philippe MoreauHematology Department, Nantes University Hospital, Nantes, France.
Béatrice GauglerHematology Department, AP-HP, Saint-Antoine Hospital, Paris, France.
Ibrahim Yakoub-AghaBone Marrow Transplantation Unit, Lille University Hospital, Lille, France.
Mohamad MohtyHematology Department, AP-HP, Saint-Antoine Hospital, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Thirty patients, with high-risk acute myeloid leukemia (AML, n = 20) or myelodysplastic syndrome (MDS, n = 10), were enrolled in a phase II trial entailing prophylactic post-transplant azacitidine (AZA) plus escalated doses of donor lymphocyte infusion (DLI). The median number of AZA cycles was 5 (1-12) with 10 patients (33%) completing the 12 projected cycles. DLI were performed in 17 patients: 5 received one DLI, 2 received 2 DLI and 8 received 3 infusions. AZA was well tolerated, but discontinued in 20 patients primarily due to graft-versus-host disease (GvHD) and relapse. The cumulative incidence (CI) of grade 1-3 acute GvHD was 31.5% and the chronic GvHD CI was 53% at 2 years. At a median follow-up of 49 months (27-63), 18 patients are alive. The overall and disease-free survivals are 65.5% (CI 95% = 48.2-82.8) at 2 years. Cause of death was mainly relapse for 9 patients. The median time to relapse was 7 months (2.5-58) and the cumulative incidence of relapse at 2 years was 27.6% (CI 95% = 12.8-44.6). These results confirm that AZA is well tolerated as a prophylactic treatment to reduce the risk of post-transplantation relapse and compared favorably to those of patients who receive no post-transplant maintenance.

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationLeukemia, Myeloid, AcuteLymphocyte TransfusionMyelodysplastic SyndromesUnrelated DonorsAdolescentAdultAgedAllograftsAzacitidineDisease-Free SurvivalFemaleHumansIncidenceMaleAzacitidineazacitidinedonor lymphocyte infusionrelapse prevention

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.