Evidence map›Paper›PMID 33449377›Full record

Trial reportCancer2021

Phase 2 study of lenalidomide maintenance for patients with high-risk acute myeloid leukemia in remission.

Iman Abou Dalle, Hagop M Kantarjian, Farhad Ravandi, Naval Daver, Xuemei Wang, Elias Jabbour, Zeev Estrov, Courtney D DiNardo, Naveen Pemmaraju, Alessandra Ferrajoli and 11 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

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

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Maintenance Therapy in AML.Frontiers in oncology · 2020
    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

21 authors at 2 institutions in 3 countries.

Iman Abou DalleHematology-Oncology Division, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.ORCID 0000-0002-6520-9134
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1908-3307
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Naval DaverDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-7103-373X
Xuemei WangDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4465-6119
Zeev EstrovDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Courtney D DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-9003-0390
Naveen PemmarajuDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Alessandra FerrajoliDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Sa A WangDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Nadya JammalDepartment of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-1457-178X
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Kiran NaqviDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-5511-6153
Sarah PelletierDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Sherry PierceDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael AndreeffDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-3631-2482
Jorge E CortesGeorgia Cancer Center, Augusta, Georgia.
Tapan M KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9892-9832
The University of Texas MD Anderson Cancer Center · USNational Cancer Center of Georgia · GE

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
CelgeneNCI NIH HHS P30 CA016672NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundNew drug combinations have led to significant improvements in remission rates for patients with acute myeloid leukemia (AML). However, many patients with high-risk AML who respond to their initial treatment and are not candidates for allogeneic stem cell transplantation (ASCT) will eventually relapse with poor outcomes.

methodsIn this phase 2 trial, the efficacy of lenalidomide maintenance was evaluated in patients with high-risk AML who had achieved their first or second remission after induction chemotherapy and at least 1 consolidation cycle and who were not candidates for immediate ASCT. Lenalidomide was given orally at 10 to 20 mg daily on days 1 to 28 of a 28-day cycle for up to 24 cycles.

resultsA total of 28 patients were enrolled in this study with a median age of 61 years (range, 24-87 years). The median number of cycles was 8 (range, 1-24 cycles). Ten patients (36%) completed 24 months of maintenance treatment. With a median follow-up of 22.5 months (range, 2.6-55 months), 12 patients (43%) relapsed after a median of 3 months (range, 0.7-23 months). The median duration of remission for all patients was 18.7 months (range, 0.7-55.1 months). The 2-year overall survival and relapse-free survival rates from the time of enrollment were 63% and 50%, respectively. Overall, lenalidomide was well tolerated; serious adverse events of grade 3 or 4, including rash (n = 5), thrombocytopenia (n = 4), neutropenia (n = 4), and fatigue (n = 2), were observed in 13 patients (46%).

conclusionsLenalidomide is a safe and feasible maintenance strategy in patients with high-risk AML who are not candidates for ASCT, and it has beneficial effects for patients with negative measurable residual disease.

Indexed as

Angiogenesis InhibitorsLenalidomideLeukemia, Myeloid, AcuteMaintenance ChemotherapyAdultAgedAged, 80 and overHematopoietic Stem Cell TransplantationHumansMiddle AgedRemission InductionRisk AssessmentYoung AdultAngiogenesis InhibitorsLenalidomideacute myeloid leukemia (AML)immunomodulationlenalidomidemaintenance

Identifiers

PMID33449377
PMCPMC11949113
OpenAlexW3119197087

What OpenQuestion holds

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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.