Evidence map›Paper›PMID 33792630›Full record

Trial reportBlood advances2021

Prognostic value of measurable residual disease after venetoclax and decitabine in acute myeloid leukemia.

Abhishek Maiti, Courtney D DiNardo, Sa A Wang, Jeffrey Jorgensen, Tapan M Kadia, Naval G Daver, Nicholas J Short, Musa Yilmaz, Naveen Pemmaraju, Gautam Borthakur and 23 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03404193 (A Phase II Study of Venetoclax in Combination With 10-Day Decitabine in Newly Diagnosed Elderly or Relapsed/Refractory Acute Myeloid Leukemia and Relapsed High-Risk Myelodysplastic Syndrome and Blastic Plasmacytoid Dendritic Cell Neoplasm), which is not on this map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
–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.

NCT03404193 phase2terminatednot on this map

A Phase II Study of Venetoclax in Combination With 10-Day Decitabine in Newly Diagnosed Elderly or Relapsed/Refractory Acute Myeloid Leukemia and Relapsed High-Risk Myelodysplastic Syndrome and Blastic Plasmacytoid Dendritic Cell Neoplasm

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2018 to 2026Enrolled235ConditionsAcute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myelomonocytic LeukemiaArmsDecitabine, Laboratory Biomarker Analysis, Venetoclax
3 · Its place in the literature

Who cites it

49 citing papers in PubMed.

  1. Trial
  2. Measurable Residual Disease Response and Prognosis in Treatment-Naïve Acute Myeloid Leukemia With Venetoclax and Azacitidine.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Minimal Residual Disease in Acute Myeloid Leukemia: Old and New Concepts.International journal of molecular sciences · 2024
    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

33 authors.

Abhishek MaitiDepartment of Leukemia.
Courtney D DiNardoDepartment of Leukemia.
Sa A WangDepartment of Hematopathology.
Jeffrey JorgensenDepartment of Hematopathology.
Tapan M KadiaDepartment of Leukemia.
Naval G DaverDepartment of Leukemia.
Nicholas J ShortDepartment of Leukemia.
Musa YilmazDepartment of Leukemia.
Naveen PemmarajuDepartment of Leukemia.
Gautam BorthakurDepartment of Leukemia.
Prithviraj BoseDepartment of Leukemia.
Ghayas C IssaDepartment of Leukemia.
Alessandra FerrajoliDepartment of Leukemia.
Elias J JabbourDepartment of Leukemia.
Nitin JainDepartment of Leukemia.
Guillermo Garcia-ManeroDepartment of Leukemia.
Maro OhanianDepartment of Leukemia.
Koichi TakahashiDepartment of Leukemia.
Guillermo Montalban-BravoDepartment of Leukemia.
Lucia MasarovaDepartment of Leukemia.
Jan A BurgerDepartment of Leukemia.
Philip A ThompsonDepartment of Leukemia.
Srdan VerstovsekDepartment of Leukemia.
Koji SasakiDepartment of Leukemia.
Michael AndreeffDepartment of Leukemia.
Caitlin R RauschDivision of Pharmacy, and.
Kathryn S MontalbanoDepartment of Leukemia.
Sherry PierceDepartment of Leukemia.
Wei QiaoDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Jing NingDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Hagop M KantarjianDepartment of Leukemia.
Marina Y KonoplevaDepartment of Leukemia.
Farhad RavandiDepartment of Leukemia.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Targeting mitochondrial complex I in acute lymphoblastic leukemiaR01CA231364 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KONOPLEVA, MARINA Y · 2019 to 2024
$2.9M
Targeting apoptosis in high-risk AML and MDS with BCL-2 inhibitor Venetoclax and optimized 10-day Decitabine regimenR01CA235622 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KONOPLEVA, MARINA Y, SPENCER, DAVID H · 2019 to 2024
$1.8M
NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA231364NCI NIH HHS R01 CA235622
6 · The paper itself

Abstract

Assessment of measurable residual disease (MRD) provides prognostic information in acute myeloid leukemia (AML). However, the utility of MRD with venetoclax-based lower intensity regimens is unknown. We analyzed the prognostic value of achieving a negative MRD in older/"unfit" patients with AML receiving first-line therapy with 10-day decitabine and venetoclax. MRD was evaluated in bone marrow specimens using multicolor flow cytometry (sensitivity 0.1%). Ninety-seven patients achieving either a complete remission (CR) or CR with incomplete hematologic recovery (CRi) or morphologic leukemia-free state were included. Median age was 72 years (interquartile range, 68-78 years), and 64% had adverse-risk AML. Eighty-three patients achieved CR/CRi, and 52 (54%) became MRD negative. Median time to becoming MRD negative was 2.0 months (interquartile range, 0.9-3.1 months). Patients becoming MRD negative by 2 months had longer relapse-free survival (RFS) compared with those remaining MRD positive (median RFS, not reached vs 5.2 months; hazard ratio [HR], 0.31; 95% confidence interval [CI], 0.12-0.78; P = .004), longer event-free survival (EFS) (median EFS, not reached vs 5.8 months; HR, 0.25; 95% CI, 0.12-0.55; P < .001), as well as longer overall survival (OS) (median OS, 25.1 vs 7.1 months; HR, 0.23; 95% CI, 0.11-0.51; P < .001). Patients achieving an MRD-negative CR had longer OS compared with those with an inferior response (median OS, 25.1 vs 11.6 months; HR, 0.33; 95% CI, 0.19-0.58; P < .0005). Patients becoming MRD negative within 1 month had an improved OS compared with MRD-positive patients (median OS, 25.1 vs 3.4 months; HR, 0.15; 95% CI, 0.03-0.64; P < .0001). Differential impact of MRD status on survival outcomes persisted at a later 4-month time point of evaluation. In conclusion, MRD-negative status at 1, 2, and 4 months after starting therapy confers significantly better survival in older/unfit patients with AML receiving first-line therapy with 10-day decitabine and venetoclax. This trial was registered at www.clinicaltrials.gov as #NCT03404193.

Indexed as

Bridged Bicyclo Compounds, HeterocyclicLeukemia, Myeloid, AcuteAgedDecitabineHumansPrognosisSulfonamidesBridged Bicyclo Compounds, HeterocyclicDecitabineSulfonamidesvenetoclax

Identifiers

PMID33792630
PMCPMC8045494

What OpenQuestion holds

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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.