Evidence map›Paper›PMID 25397619›Full record

Trial reportBlood cancer journal2014

Ofatumumab and high-dose methylprednisolone for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia.

J E Castro, M Y Choi, T Carvajal, E Almahasnah, J Chang, D F James, T J Kipps

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood cancer journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. Review
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

7 authors.

J E Castro1] Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA [2] Chronic Lymphocytic Leukemia Research Consortium (CRC), La Jolla, CA, USA.
M Y Choi1] Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA [2] Chronic Lymphocytic Leukemia Research Consortium (CRC), La Jolla, CA, USA.
T CarvajalDepartment of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
E AlmahasnahDepartment of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
J ChangDepartment of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
D F JamesDepartment of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA.
T J Kipps1] Department of Medicine, University of California, San Diego Moores Cancer Center, La Jolla, CA, USA [2] Chronic Lymphocytic Leukemia Research Consortium (CRC), La Jolla, CA, USA.

Funding

Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
NCI NIH HHS NIH 5P01CA081534-14NCI NIH HHS P01 CA081534
6 · The paper itself

Abstract

Ofatumumab is a humanized anti-CD20 monoclonal antibody that has been approved by the FDA for the treatment of patients with chronic lymphocytic leukemia. We conducted a phase II single-arm study at a single center. Patients received ofatumumab (300 mg then 1000 mg weekly for 12 weeks) and methylprednisolone (1000 mg/m(2) for 3 days of each 28-day cycle). Twenty-one patients enrolled, including 29% with unfavorable cytogenetics (del17p or del11q). Ninety percent of patients received the full course without dose reductions or delays. The overall response rate was 81% (17/21) with 5% complete response, 10% nodular partial response, 67% partial response, 14% stable disease and 5% progressive disease. After a median follow-up of 31 months, the median progression-free survival was 9.9 months and the median time to next treatment was 12.1 months. The median overall survival has not yet been reached. The combination of high-dose methylprednisolone and ofatumumab is an effective and tolerable treatment regimen. This regimen may be useful for patients who are unable to tolerate more aggressive therapies, or have not responded to other treatments.

Indexed as

AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChromosome DeletionChromosomes, Human, Pair 11Chromosomes, Human, Pair 17Disease-Free SurvivalFemaleFollow-Up StudiesHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMethylprednisoloneMiddle AgedRecurrenceAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedMethylprednisoloneofatumumab

Identifiers

PMID25397619
PMCPMC4571984

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Registered trials

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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.