Evidence map›Paper›PMID 33231879›Full record

Trial reportCancer2021

Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia.

Wendy Stock, Giovanni Martinelli, Matthias Stelljes, Daniel J DeAngelo, Nicola Gökbuget, Anjali S Advani, Susan O'Brien, Michaela Liedtke, Akil A Merchant, Ryan D Cassaday and 6 more

3 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
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. It is linked to 3 registered trials, which are not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
5.6field-weighted citation impact, top 3% 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
NCT07476729 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2026 to 2033Enrolled750ConditionsB-Cell Acute Lymphoblastic LeukaemiaArmsInotuzumab ozogamicin (INO), Blinatumomab
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.

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  16. Revisiting novel genomic classifiers in the era of immunotherapy for pediatric B-ALL.Hematology. American Society of Hematology. Education Program · 2025
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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

16 authors at 14 institutions in 5 countries.

Wendy StockSection of Hematology/Oncology, Department of Medicine, and University of Chicago Comprehensive Cancer Center, University of Chicago, Chicago, Illinois.
Giovanni MartinelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
Matthias StelljesUniversitätsklinikum Münster, Münster, Germany.
Daniel J DeAngeloDana-Farber Cancer Institute, Boston, Massachusetts.
Nicola GökbugetGoethe University, Frankfurt, Germany.
Anjali S AdvaniCleveland Clinic Taussig Cancer Institute, Cleveland, Ohio.
Susan O'BrienChao Family Comprehensive Cancer Center, University of California Irvine, Orange, California.
Michaela LiedtkeStanford Cancer Institute, Stanford, California.
Akil A MerchantCedars Sinai Medical Center, Los Angeles, California.
Ryan D CassadayUniversity of Washington School of Medicine and Fred Hutchinson Cancer Research Center, Seattle, Washington.ORCID 0000-0002-3424-2425
Tao WangPfizer Inc, Cambridge, Massachusetts.
Hui ZhangPfizer Inc, Shanghai, China.
Erik VandendriesPfizer Inc, Cambridge, Massachusetts.
Elias JabbourUniversity of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4465-6119
David I MarksUniversity Hospitals Bristol, Bristol, UK.
Hagop M KantarjianUniversity of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1908-3307
Pfizer (United States) · USThe University of Texas MD Anderson Cancer Center · USCancer Prevention Institute of California · USCedars-Sinai Medical Center · USCleveland Clinic · USDana-Farber Cancer Institute · USGoethe University Frankfurt · DEIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITPfizer (China) · CNUniversity Hospital Münster · DEUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of California, Irvine · USUniversity of Chicago · USUniversity of Washington · US

Funding

Pfizer Inc
6 · The paper itself

Abstract

backgroundPatients with relapsed/refractory (R/R) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) have a poor prognosis and limited treatment options.

methodsThe efficacy of inotuzumab ozogamicin (InO), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, was evaluated in R/R ALL patients in the phase 1/2 study 1010 (NCT01363297) and open-label, randomized, phase 3 study 1022 (INO-VATE; NCT01564784). This analysis focused specifically on Ph+ R/R ALL patients. In study 1022, Ph+ patients were randomly assigned 1:1 to InO (n = 22) or standard intensive chemotherapy (SC) (n = 27) and 16 Ph+ patients in study 1010 received InO.

resultsIn study 1022, rates of complete remission/complete remission with incomplete hematologic recovery (CR/CRi) and minimal residual disease (MRD) negativity (patients achieving CR/CRi) were higher with InO (CR/CRi = 73%; MRD = 81%) versus SC (CR/CRi = 56%; MRD = 33%). The corresponding rates in study 1010 were 56% (CR/CRi) and 100% (MRD). The hematopoietic stem cell transplantation (HSCT) rate in study 1022 was 41% versus 19% for InO versus SC; however, there was no benefit in overall survival (median OS: 8.7 vs 8.4 months; hazard ratio, 1.17 [95% CI, 0.64-2.14]). The probability of being event-free (progression-free survival) at 12 months was greater with InO versus SC (20.1% vs 4.8%).

conclusionGiven the substantial improvement in responses and rates of HSCT, InO is an important treatment option for patients with R/R Ph+ ALL. Future studies need to consider better characterization of disease characteristics, more sensitive MRD measurements, MRD-directed therapy before HSCT, and potentially combination therapies, including tyrosine kinase inhibitors.

Indexed as

Hematopoietic Stem Cell TransplantationHumansInotuzumab OzogamicinNeoplasm, ResidualPhiladelphia ChromosomePrecursor Cell Lymphoblastic Leukemia-LymphomaRecurrenceInotuzumab Ozogamicinacute lymphoblastic leukemiaefficacyhematopoietic stem cell transplantationinotuzumab ozogamicinPhiladelphia chromosome

Identifiers

PMID33231879
PMCPMC7983935
OpenAlexW3109133697

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-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.