Evidence map›Paper›PMID 38170741›Full record

ArticleBlood advances2024

A multicenter study of posttransplantation low-dose inotuzumab ozogamicin to prevent relapse of acute lymphoblastic leukemia.

Leland L Metheny, Ronald Sobecks, Christina Cho, Pingfu Fu, Seunghee Margevicius, Jiasheng Wang, Lisa Ciarrone, Shelby Kopp, Robin D Convents, Navneet Majhail and 11 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
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 NCT03104491 (Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
14.7field-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.

NCT03104491 phase1 / phase2recruitingnot on this map

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

TypeinterventionalSponsorLeland MethenyRan2017 to 2027Enrolled44ConditionsAcute Lymphocytic LeukemiaArmsInotuzumab Ozogamicin
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Peri-transplant conundrums: optimizing maintenance therapy using MRD-directed approaches.Hematology. American Society of Hematology. Education Program · 2025
    Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Transplant in ALL: who, when, and how?Hematology. American Society of Hematology. Education Program · 2024
    Review
  17. Maintenance strategies for relapse prevention and treatment.Hematology. American Society of Hematology. Education Program · 2024
    Review
  18. Review
  19. Article
  20. 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 6 institutions in 1 country.

Leland L MethenyHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.ORCID 0000-0002-1980-9999
Ronald SobecksCase Comprehensive Cancer Center, Cleveland, OH.
Christina ChoAdult Bone Marrow Transplantation Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Pingfu FuDepartment of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.ORCID 0000-0002-2334-5218
Seunghee MargeviciusDepartment of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH.
Jiasheng WangHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Lisa CiarroneHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Shelby KoppHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Robin D ConventsHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Navneet MajhailCase Comprehensive Cancer Center, Cleveland, OH.ORCID 0000-0001-7082-891X
Paolo F CaimiCase Comprehensive Cancer Center, Cleveland, OH.ORCID 0000-0003-1436-0464
Folashade OtegbeyeClinical Research Division, Fred Hutchison Cancer Center, Seattle, WA.
Brenda W CooperHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Molly GalloglyHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Ehsan MalekHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Benjamin TomlinsonHematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.ORCID 0000-0002-2407-0973
Aaron T GerdsCase Comprehensive Cancer Center, Cleveland, OH.ORCID 0000-0002-3422-1309
Betty HamiltonCase Comprehensive Cancer Center, Cleveland, OH.
Sergio GiraltAdult Bone Marrow Transplantation Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-1944-5053
Miguel-Angel PeralesAdult Bone Marrow Transplantation Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5910-4571
Marcos de LimaHematology, The Ohio State University, Columbus, OH.ORCID 0000-0002-8568-4522
University Hospitals Seidman Cancer Center · USCleveland Clinic · USMemorial Sloan Kettering Cancer Center · USCase Western Reserve University · USFred Hutch Cancer Center · USThe Ohio State University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
TUMOR METABOLISM PROGRAMP30CA043703 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI Amar Desai · 1987 to 2026
$142.3M
T LYMPHOCYTE SUBSET FUNCTION POST-TRANSPLANTATIONP01CA023766 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SCHEINBERG, DAVID A · 1985 to 2023
$59.0M
NCI NIH HHS P01 CA023766NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA043703
6 · The paper itself

Abstract

abstractThe curative potential of allogeneic hematopoietic transplantation (allo-HCT) in patients with acute lymphoblastic leukemia (ALL) is hampered by relapse. Inotuzumab ozogamicin (INO) is an anti-CD22 monoclonal antibody bound to calicheamicin, which has significant activity against ALL. We hypothesized that low-dose INO would be safe and feasible after allo-HCT. Therefore, we conducted a phase 1 study to determine the dose and safety in this setting. Patients were eligible if they were aged 16 to 75 years, had undergone allo-HCT for CD22+ ALL, were in complete remission (CR) after allo-HCT, had high risk of recurrence, were between day 40 and 100 after allo-HCT with adequate graft function, and did not have a history of sinusoidal obstruction syndrome (SOS). The objectives of this trial were to define INO maximum tolerated dose (MTD), to determine post-allo-HCT INO safety, and to measure 1-year progression-free survival (PFS). The trial design followed a "3+3" model. The treatment consisted of INO given on day 1 of 28-day cycles. Dose levels were 0.3 mg/m2, 0.4 mg/m2, 0.5 mg/m2, and 0.6 mg/m2. Median age was 44 years (range, 17-66 years; n = 18). Disease status at transplantation was first CR (n = 14) or second CR or beyond (n = 4). Preparative regimen was of reduced intensity in 72% of patients who received transplantation. Most common toxicity was thrombocytopenia. There were no instances of SOS; the MTD was 0.6 mg/m2. One-year nonrelapse mortality was 5.6%. With a median follow-up of 18.1 months (range, 8.6-59 months) 1-year post-allo-HCT PFS and overall survival is 89% and 94%, respectively. Low-dose INO has a favorable safety profile and was associated with high rates of 1-year PFS. This trial was registered at www.clinicaltrials.gov as #NCT03104491.

Indexed as

Antibodies, Monoclonal, HumanizedPrecursor Cell Lymphoblastic Leukemia-LymphomaAdultAntineoplastic Combined Chemotherapy ProtocolsHumansInotuzumab OzogamicinRecurrenceAntibodies, Monoclonal, HumanizedInotuzumab Ozogamicin

Identifiers

PMID38170741
PMCPMC10945150
OpenAlexW4390572415

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.