Evidence map›Paper›PMID 38197938›Full record

ArticleBlood advances2024

Prophylactic maintenance with venetoclax/azacitidine after reduced-intensity conditioning allogeneic transplant for high-risk MDS and AML.

Jacqueline S Garcia, Haesook T Kim, H Moses Murdock, Michela Ansuinelli, Jennifer Brock, Corey S Cutler, Mahasweta Gooptu, Vincent T Ho, John Koreth, Sarah Nikiforow and 13 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Blood advances, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03613532 (A Phase 1 Study of Adding Venetoclax to a Reduced Intensity Conditioning Regimen and to Maintenance in Combination With a Hypomethylating Agent After Allogeneic Hematopoietic Cell Transplantation for Patients With High Risk AML, MDS, and MDS/MPN Overlap Syndromes), which is not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
16.4field-weighted citation impact, top 1% of its field
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.

NCT03613532 phase1active not recruitingnot on this map

A Phase 1 Study of Adding Venetoclax to a Reduced Intensity Conditioning Regimen and to Maintenance in Combination With a Hypomethylating Agent After Allogeneic Hematopoietic Cell Transplantation for Patients With High Risk AML, MDS, and MDS/MPN Overlap Syndromes

TypeinterventionalSponsorJacqueline Garcia, MDRan2018 to 2030Enrolled102ConditionsAcute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), MDS/Myeloproliferative Neoplasm-unclassifiable (MDS/MPN-unclassifiable)ArmsVenetoclax, Fludarabine, Busulfan, Azacitidine, Decitabine/cedazuridine
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 36 citations in OpenAlex.

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  20. AML, Myelodysplasia-Related: Beyond Classification-Toward Precision Decision-Making.Mediterranean journal of hematology and infectious diseases · 2026
    Review
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

23 authors at 2 institutions in 2 countries.

Jacqueline S GarciaDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0003-2118-6302
Haesook T KimDepartment of Data Science, Dana-Farber Cancer Institute, Boston, MA.
H Moses MurdockDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0003-4098-8968
Michela AnsuinelliDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-3424-915X
Jennifer BrockDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Corey S CutlerDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Mahasweta GooptuDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Vincent T HoDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
John KorethDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Sarah NikiforowDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Rizwan RomeeDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Roman ShapiroDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Daniel J DeAngeloDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-7865-2306
Richard M StoneDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Denbaa Bat-ErdeneDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Jeremy RyanDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-3327-1283
Manuel E ContrerasDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Geoffrey FellDepartment of Data Science, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-6436-6691
Anthony LetaiDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Jerome RitzDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
R Coleman LindsleyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-9822-806X
Robert J SoifferDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Joseph H AntinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Dana-Farber Cancer Institute · USHarvard University · US

Funding

TYROSINE KINASE ONCOGENESIS IN MYELOID LEUKEMIAP01CA066996 · NCI · DANA-FARBER CANCER INSTITUTE · PI SCOTT A ARMSTRONG · 1996 to 2026
$52.5M
Single Cell and ImmunogenomicsP01CA229092 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME · 2019 to 2023
$13.8M
Reading mitochondrial apoptotic signaling to identify active cancer therapeuticsR35CA242427 · NCI · DANA-FARBER CANCER INST · PI LETAI, ANTHONY G · 2019 to 2025
$7.0M
Enhancing Venetoclax Activity in Chemoresistant Acute Myeloid LeukemiaK08CA245209 · NCI · DANA-FARBER CANCER INST · PI GARCIA, JACQUELINE SUEN · 2020 to 2024
$1.3M
NCI NIH HHS K08 CA245209NCI NIH HHS P01 CA066996NCI NIH HHS P01 CA229092NCI NIH HHS R35 CA242427
6 · The paper itself

Abstract

abstractWe conducted a phase 1 trial assessing safety and efficacy of prophylactic maintenance therapy with venetoclax and azacitidine (Ven/Aza) for patients with high-risk myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) undergoing reduced intensity allogeneic stem cell transplantation (allo-SCT) after Ven and fludarabine/busulfan conditioning (Ven/FluBu2 allo-SCT) with tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis. Among 27 patients who underwent Ven/FluBu2 allo-SCT (55.6% with prior Ven exposure, and 96% with positive molecular measurable residual disease), 22 received maintenance therapy with Aza 36 mg/m2 intravenously on days 1 to 5, and Ven 400 mg by mouth on days 1 to 14 per assigned dose schedule/level (42-day cycles × 8, or 28-day cycles × 12). During maintenance, the most common grade 3-4 adverse events were leukopenia, neutropenia, and thrombocytopenia, which were transient and manageable. Infections were uncommon (n = 4, all grade 1-2). The 1-year and 2-year moderate/severe chronic GVHD rates were 4% (95% confidence interval [CI], 0.3%-18%) and 22% (95% CI, 9%-40%), respectively. After a median follow-up of 25 months among survivors, the median overall survival (OS) was not reached. Among the 22 patients who received Ven/Aza maintenance, the 2-year OS, progression-free survival, nonrelapse mortality, and cumulative incidence of relapse rates were 67% (95% CI, 43%-83%), 59% (95% CI, 36%-76%), 0%, and 41% (95% CI, 20%-61%), respectively. Immune monitoring demonstrated no significant impact on T-cell expansion but identified reduced B-cell expansion compared with controls. This study demonstrates prophylactic Ven/Aza maintenance can be safely administered for patients with high-risk MDS/AML, but a randomized study is required to properly assess any potential benefit. This trial was registered at www.clinicaltrials.gov as #NCT03613532.

Indexed as

Bridged Bicyclo Compounds, HeterocyclicGraft vs Host DiseaseLeukemia, Myeloid, AcuteSulfonamidesAzacitidineHumansTransplantation ConditioningTransplantation, HomologousAzacitidineBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclax

Identifiers

PMID38197938
PMCPMC10883823
OpenAlexW4390707197

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

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.