Evidence map›Paper›PMID 19860603›Full record

Trial reportLeukemia & lymphoma2009

A phase I/II dose escalation study of apolizumab (Hu1D10) using a stepped-up dosing schedule in patients with chronic lymphocytic leukemia and acute leukemia.

Thomas S Lin, Wendy Stock, Huiping Xu, Mitch A Phelps, Margaret S Lucas, Sara K Guster, Bruce R Briggs, Carolyn Cheney, Pierluigi Porcu, Ian W Flinn and 3 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Leukemia & lymphoma, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.2field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 35 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Thrombotic microangiopathy with targeted cancer agents.Clinical cancer research : an official journal of the American Association for Cancer Research · 2011
    Review
  12. Article
  13. Investigational immunotherapeutics for B-cell malignancies.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010
    Review
  14. Article
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Thomas S LinDivision of Hematology and Oncology, The Ohio State University, Columbus, OH 43210, USA.
Wendy Stock
Huiping Xu
Mitch A Phelps
Margaret S Lucas
Sara K Guster
Bruce R Briggs
Carolyn Cheney
Pierluigi Porcu
Ian W Flinn
Michael R Grever
James T Dalton
John C Byrd
The Ohio State University · USSarah Cannon · USUniversity of Chicago · US

Funding

PHASE I TRIALS OF ANTICANCER AGENTSU01CA076576 · NCI · OHIO STATE UNIVERSITY · PI GREVER, MICHAEL R · 1998 to 2013
$9.1M
Hu1D10 in CLL: CLINICAL AND LABORATORY STUDIESR01CA102504 · NCI · OHIO STATE UNIVERSITY · PI BYRD, JOHN C · 2003 to 2006
$1.2M
Monoclonal Antibody Therapy in B-Cell CLL.K23CA102276 · NCI · OHIO STATE UNIVERSITY · PI LIN, THOMAS S · 2004 to 2008
$659k
NCI NIH HHS 1 K23 CA102276-01A1NCI NIH HHS CA102504NCI NIH HHS K23 CA102276NCI NIH HHS R01 CA102504NCI NIH HHS U01 CA076576NCI NIH HHS U01 CA 76576
6 · The paper itself

Abstract

Apolizumab (Hu1D10), a humanized monoclonal anti- Human leukocyte antigen -DR beta-chain antibody, mediates apoptosis of chronic lymphocytic leukemia (CLL) cells in vitro. We conducted a phase I/II dose-escalation study of thrice-weekly apolizumab (1.5, 3.0, 5.0 mg/kg/dose) for 4 weeks in relapsed CLL. Two of six patients at 5.0 mg/kg/dose developed treatment-related dose-limiting toxicity (aseptic meningitis, hemolytic uremia). Other toxicities included infusion toxicity, urticaria, and headache. Eleven patients were enrolled in a phase I/II expansion to evaluate the maximum tolerated dose (MTD) of 3.0 mg/kg/dose. In total, 23 patients were enrolled (22 CLL, 1 ALL). Nineteen patients with CLL were treated at or above the MTD. One partial response was observed, and three patients had stable disease exceeding 6 months. Pharmacokinetic analysis demonstrated a dose-dependent C(max) increase and serum antibody accumulation after week 1 of therapy. Given the toxicity and lack of efficacy in this and other trials in lymphoma and solid tumors, further development of apolizumab was discontinued.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArea Under CurveDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleFeverHLA-DR AntigensHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMetabolic Clearance RateMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedapolizumabHLA-DR Antigens

Identifiers

PMID19860603
PMCPMC8166408
OpenAlexW2132618329

What OpenQuestion holds

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Registered trials

None linked

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.