Evidence map›Paper›PMID 39916320›Full record

Trial reportCancer2025

Results of Cancer and Leukemia Group B 10102 (Alliance), a Phase 1/2 Study.

Marlise R Luskin, Jun Yin, Gerard Lozanski, Emily Curran, Gregory Malnassy, Krzysztof Mrózek, Clara D Bloomfield, Spero R Cataland, Noreen Fulton, Jonathan Kolitz and 10 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00061945 (A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT00061945 phase1 / phase2completednot on this map

A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2003 to 2012Enrolled302ConditionsAcute Undifferentiated Leukemia, B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, L1 Adult Acute Lymphoblastic LeukemiaArmsallopurinol, cyclophosphamide, daunorubicin hydrochloride, vincristine sulfate, dexamethasone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Marlise R LuskinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-5781-4529
Jun YinDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida, USA.
Gerard LozanskiDepartment of Pathology, The Ohio State University Medical Center, Columbus, Ohio, USA.
Emily CurranUniversity of Cincinnati Cancer Center, Cincinnati, Ohio, USA.
Gregory MalnassyDepartment of Pathology, University of Chicago, Chicago, Illinois, USA.
Krzysztof MrózekClara D. Bloomfield Center for Leukemia Outcomes Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Clara D BloomfieldThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Spero R CatalandDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Noreen FultonDepartment of Medicine and Comprehensive Cancer Center, University of Chicago, Chicago, Illinois, USA.
Jonathan KolitzNorthwell Health Cancer Institute, Lake Success, New York, USA.
Betsy LaplantAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota, USA.
Oudom KourAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota, USA.
Bayard L PowellAtrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, USA.
Ravi VijDivision of Medical Oncology, Washington University School of Medicine, St Louis, Missouri, USA.
Eunice S WangLeukemia Service, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.ORCID https://orcid.org/0000-0002-8644-0968
David GrinblattNorthShore HealthSystem-Evanston Hospital, Evanston, Illinois, USA.
Richard M StoneDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Geoffrey L UyDivision of Medical Oncology, Washington University School of Medicine, St Louis, Missouri, USA.
Richard A LarsonDepartment of Medicine and Comprehensive Cancer Center, University of Chicago, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0001-9168-3203
Wendy StockDepartment of Medicine and Comprehensive Cancer Center, University of Chicago, Chicago, Illinois, USA.

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Wake Forest NCORP Research BaseUG1CA189824 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Emily Van Meter Dressler, GLENN J LESSER · 2014 to 2026
$57.9M
THE ALLIANCE NCTN BIOREPOSITORY AND BIOSPECIMEN RESOURCEU24CA196171 · NCI · WASHINGTON UNIVERSITY · PI Mine Cicek, Wendy Frankel · 2015 to 2026
$35.0M
Delaware Christiana Care NCORPUG1CA189819 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GREGORY A MASTERS · 2014 to 2026
$21.6M
Northwell Health NCORPUG1CA189850 · NCI · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI VINCENT P VINCIGUERRA · 2014 to 2026
$13.3M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
National Capital Area (NCA) NCI Community Oncology Research Program (NCORP)UG1CA239758 · NCI · GEORGETOWN UNIVERSITY · PI Lucile L. Adams-Campbell, Chiranjeev Dash · 2019 to 2026
$6.3M
UG1 - NCTN (Network Lead)UG1CA233327 · NCI · UNIVERSITY OF CHICAGO · PI STEVEN J CHMURA, HEDY L KINDLER · 2019 to 2026
$4.4M
The Duke University - Duke Cancer Institute National Clinical Trials Network LAPS (UG1) Support GrantUG1CA233253 · NCI · DUKE UNIVERSITY · PI John H Strickler, Alexandra Thomas · 2019 to 2026
$3.7M
BayerNCI NIH HHS R50 CA275927NCI NIH HHS U10 CA180821NCI NIH HHS U10CA180821NCI NIH HHS U10 CA180882NCI NIH HHS U10CA180882NCI NIH HHS U24 CA196171NCI NIH HHS U24CA196171NCI NIH HHS UG1 CA189819NCI NIH HHS UG1 CA189824NCI NIH HHS UG1CA189824NCI NIH HHS UG1 CA189850NCI NIH HHS UG1CA189850NCI NIH HHS UG1 CA233180NCI NIH HHS UG1CA233180NCI NIH HHS UG1 CA233191NCI NIH HHS UG1CA233191NCI NIH HHS UG1 CA233253NCI NIH HHS UG1 CA233323NCI NIH HHS UG1 CA233327NCI NIH HHS UG1CA233327NCI NIH HHS UG1 CA233331NCI NIH HHS UG1CA233331NCI NIH HHS UG1 CA233339NCI NIH HHS UG1CA233339NCI NIH HHS UG1 CA233373NCI NIH HHS UG1 CA239758Sanofi Genzyme
6 · The paper itself

Abstract

backgroundAcute lymphoblastic leukemia (ALL) in adults is aggressive, with long-term outcomes impacted by treatment resistance and toxicity. CD52 is expressed in most cases of B- and T-lineage ALL. Alemtuzumab, a humanized immunoglobulin G1 monoclonal antibody that targets CD52, was identified as a potential agent to improve treatment efficacy without increasing toxicity.

methodsIn this phase 1/2 study (Cancer and Leukemia Group B [CALGB] 10102, NCT00061945), a course of single-agent alemtuzumab was intercalated into CALGB 19802 backbone chemotherapy after the third course of intensive chemotherapy in those who were CD52+ at diagnosis. Phase 1 tested three dose levels of subcutaneous alemtuzumab (10, 20, and 30 mg 3 times weekly for 4 weeks/12 doses) and demonstrated that 30 mg was tolerable. Phase 2 established feasibility.

resultsThe study enrolled 295 evaluable patients (115 in phase 1, 180 in phase 2); 206 (69.8%) were CD52+. Among evaluable CD52+ patients, 43.7% (90/206) completed the first three treatment modules; 97.8% (88 of 90) were treated with alemtuzumab. Alemtuzumab was associated with cytomegalovirus viremia, which occurred in 23.3% (14 of 60) of patients during and 29.2% (19 of 65) after alemtuzumab treatment. With a median follow-up of 101.2 months, median overall survival (OS) was 26.3 months (3-year rate, 44%; 5-year rate, 36%; 10-year rate, 31%). Landmark analysis at the start of the fourth course of treatment demonstrated no difference in OS or disease-free survival between patients who did and who did not receive alemtuzumab.

conclusionAlemtuzumab was feasible to administer in adults with ALL receiving intensive chemotherapy, but was without evidence of benefit.

Indexed as

AlemtuzumabAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsPrecursor Cell Lymphoblastic Leukemia-LymphomaAdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedCD52 AntigenFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAlemtuzumabAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCD52 AntigenCD52 protein, humanalemtuzumabALLantibodychemotherapymonoclonalolder

Identifiers

PMID39916320
PMCPMC11803179

What Socratic 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 Socratic graph.