Evidence map›Paper›PMID 32812370›Full record

ArticleClinical and translational science2021

Characterization of the Relationship of Inotuzumab Ozogamicin Exposure With Efficacy and Safety End Points in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia.

Joseph Chen, May Haughey, Erik Vandendries, Daniel J DeAngelo, Hagop M Kantarjian, Ana Ruiz-Garcia

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 29% 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.

NCT01363297 phase2completednot on this map

An Open-label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-positive Acute Lymphocytic Leukemia

TypeinterventionalSponsorPfizerRan2011 to 2016Enrolled72ConditionsAcute Lymphocytic LeukemiaArmsInotuzumab Ozogamicin
NCT01564784 phase3completednot on this map

An open-label, randomized phase 3 study of inotuzumab ozogamicin compared to a defined investigator's choice in adult patients with relapsed or refractory cd22-positive acute lymphoblastic leukemia (all)

TypeinterventionalSponsorPfizerRan2012 to 2017Enrolled326ConditionsAcute Lymphoblastic LeukemiaArmsinotuzumab ozogamicin, FLAG (fludarabine, cytarabine and G-CSF), HIDAC (high dose cytarabine), cytarabine and mitoxantrone
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
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

6 authors at 3 institutions in 1 country.

Joseph ChenPfizer Inc, New York, New York, USA.
May HaugheyPfizer Inc, San Diego, California, USA.
Erik VandendriesPfizer Inc, Cambridge, Massachusetts, USA.
Daniel J DeAngeloDana-Farber Cancer Institute, Boston, Massachusetts, USA.
Hagop M KantarjianUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ana Ruiz-GarciaPfizer Inc, San Diego, California, USA.
Pfizer (United States) · USDana-Farber Cancer Institute · USThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Inotuzumab ozogamicin (InO), an anti-CD22 monoclonal antibody conjugated to calicheamicin, is approved in Europe and the United States for treatment of adults with relapsed or refractory acute lymphoblastic leukemia (ALL). Population analyses were performed to evaluate the relationship between InO exposure and efficacy and safety end points in patients with ALL. The probability of achieving complete remission/complete remission with incomplete hematologic recovery (CR/CRi) and minimal residual disease (MRD)-negativity for InO relative to chemotherapy was also investigated. Data from study 1010 (NCT01363297) and INO-VATE (NCT01564784) were pooled for exposure-response (InO, n = 234) and treatment-response (InO, n = 234; chemotherapy, n = 143) analyses. The analyses demonstrated that InO exposure was significantly correlated with achieving CR/CRi and MRD-negativity, as well as with hepatic event adjudication board-reported veno-occlusive disease/sinusoidal obstruction. Patients with ALL treated with InO had significantly greater odds of achieving CR/CRi (7-times higher) and MRD-negativity (13-times higher) than those receiving chemotherapy.

Indexed as

AdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDrug Resistance, NeoplasmFemaleHumansInotuzumab OzogamicinMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm, ResidualPrecursor Cell Lymphoblastic Leukemia-LymphomaInotuzumab Ozogamicin

Identifiers

PMID32812370
PMCPMC7877846
OpenAlexW3053993225

What OpenQuestion holds

Textmetadata
LicenceCC BY-ND
Read underepoch 390

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.