Evidence map›Paper›PMID 37131217›Full record

Trial reportJournal of hematology & oncology2023

Results of salvage therapy with mini-hyper-CVD and inotuzumab ozogamicin with or without blinatumomab in pre-B acute lymphoblastic leukemia.

Hagop Kantarjian, Fadi G Haddad, Nitin Jain, Koji Sasaki, Nicholas J Short, Sanam Loghavi, Rashmi Kanagal-Shamanna, Jeffrey Jorgensen, Issa Khouri, Partow Kebriaei and 11 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2023. 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 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
12.8field-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.

NCT01371630 phase1 / phase2recruitingnot on this map

Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2011 to 2027Enrolled276ConditionsB Acute Lymphoblastic Leukemia With t(9, 22)(q34.1, q11.2), BCR-ABL1ArmsBlinatumomab, Cyclophosphamide, Cytarabine, Dexamethasone, Inotuzumab Ozogamicin
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

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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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

21 authors at 2 institutions in 1 country.

Hagop KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA. hkantarjian@mdanderson.org.
Fadi G HaddadDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Koji SasakiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Nicholas J ShortDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Sanam LoghaviDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Rashmi Kanagal-ShamannaDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Jeffrey JorgensenDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Issa KhouriDepartment of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Partow KebriaeiDepartment of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Yesid AlvaradoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Tapan KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Shilpa PaulDepartment of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Bouthaina DabajaDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Musa YilmazDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Jovitta JacobDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Rebecca GarrisDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Susan O'BrienChao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA, USA.
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Box 428, Houston, TX, 77030, USA.
The University of Texas MD Anderson Cancer Center · USUniversity of California, Irvine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHistorically, adults with relapsed-refractory acute lymphoblastic leukemia (ALL) experienced poor outcomes with intensive chemotherapy. This mature analysis explores the benefit of the addition of sequential blinatumomab to low-intensity mini-Hyper-CVD chemotherapy with inotuzumab ozogamicin in this setting.

methodsMini-Hyper-CVD (cyclophosphamide and dexamethasone at 50% dose reduction, no anthracycline, methotrexate at 75% dose reduction, cytarabine at 83% dose reduction) was combined with inotuzumab during the first 4 courses. From Patient #68 and onwards, inotuzumab was given in reduced and fractionated doses, and blinatumomab was added sequentially for 4 courses. Maintenance therapy with prednisone, vincristine, 6-mercaptopurine and methotrexate was given for 12 courses, and blinatumomab for 4 additional courses.

resultsAmong 110 patients (median age, 37 years) treated, 91 (83%) responded (complete response, 69 patients, 63%). Measurable residual disease negativity was documented in 75 patients (82% of responders). Fifty-three patients (48%) received allogeneic stem cell transplantation (SCT). Hepatic sinusoidal obstruction syndrome occurred in 9/67 patients (13%) on the original inotuzumab schedule and in 1/43 (2%) on the modified schedule. With a median follow-up of 48 months, the median overall survival (OS) was 17 months, and the 3 year OS was 40%. The 3 year OS was 34% with mini-Hyper-CVD plus inotuzumab and 52% with additional blinatumomab (P = 0.16). By landmark analysis at 4 months, the 3 year OS was 54%, similar between patients who did or did not receive allogeneic SCT.

conclusionLow-intensity mini-Hyper-CVD plus inotuzumab with or without blinatumomab showed efficacy in patients with relapsed-refractory ALL, with better survival after the addition of blinatumomab. Trial registration The trial was registered on clinicaltrials.gov with the identifier NCT01371630.

Indexed as

Antibodies, BispecificCardiovascular DiseasesPrecursor B-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaAdultHumansInotuzumab OzogamicinMethotrexateSalvage TherapyAntibodies, BispecificblinatumomabInotuzumab OzogamicinMethotrexateBlinatumomabChemo-immunotherapyInotuzumabOutcomePhiladelphia-negative ALLSalvage

Identifiers

PMID37131217
PMCPMC10155451
OpenAlexW4367834551

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.