Evidence map›Paper›PMID 19693094›Full record

ArticleLeukemia2009

Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia.

J E Castro, D F James, J D Sandoval-Sus, S Jain, J Bole, L Rassenti, T J Kipps

Erratum issued Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Leukemia, 2009. 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 NCT01191190 (A Phase II Study of Ofatumumab in Combination With High-dose Methylprednisolone in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia), which is not on this map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
6.2field-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.

NCT01191190 phase2completednot on this mapstarted 2010, after this paper: background citation

A Phase II Study of Ofatumumab in Combination With High-dose Methylprednisolone in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

TypeinterventionalSponsorJanuario Castro, M.D.Ran2010 to 2012Enrolled21ConditionsCLLArmsOfatumumab/HDMP
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Targeting Bcl-2-IPBiochimica et biophysica acta. Molecular cell research · 2018
    Review
  13. Review
  14. How should we sequence and combine novel therapies in CLL?Hematology. American Society of Hematology. Education Program · 2017
    Review
  15. Article
  16. Article
  17. Review
  18. Sequencing of chronic lymphocytic leukemia therapies.Hematology. American Society of Hematology. Education Program · 2016
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

J E CastroMoores UCSD Cancer Center, University of California, La Jolla, CA 92093-0820, USA.
D F James
J D Sandoval-Sus
S Jain
J Bole
L Rassenti
T J Kipps
Moores Cancer CenterUniversity of California, San Diego · US

Funding

Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GRIBBEN, JOHN G. · 2000 to 2016
$59.5M
Immunotherapy for Chronic Lymphocytic LeukemiaK08CA106605 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CASTRO, JANUARIO E · 2004 to 2008
$662k
NCI NIH HHS K08-CA106 605-01NCI NIH HHS P01 CA081534NCI NIH HHS P01-CA081534
6 · The paper itself

Abstract

We observed that high-dose methylprednisolone (HDMP) and rituximab was well tolerated and had promising activity when used in combination to treat patients with fludarabine-refractory chronic lymphocytic leukemia (CLL). This prompted us to evaluate the use of these agents in frontline therapy. A total of 28 patients with a median age of 65 years enrolled in this study. Patients received HDMP at 1 g/m(2) each day for 3 days during each of the three 4-week cycles together with rituximab and prophylactic antimicrobial therapy. The treatment was well tolerated with few adverse events of grade III or higher. The overall response rate was 96% (N=27). Nine patients (32%) achieved a complete remission (CR), two of which were without detectable minimal residual disease (MRD). Six patients with MRD received consolidation with alemtuzumab; five of these patients achieved an MRD-negative CR. With over 3 years of follow-up median progression-free survival was 30.3 months with only 39% of patients requiring additional therapy, and an overall survival was 96%. This study demonstrates that HDMP and rituximab is an effective nonmyelosuppressive treatment combination for patients with CLL that warrants consideration particularly for patients with limited myeloid reserve that might not tolerate standard treatment regimens.

Indexed as

AgedAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAnti-Inflammatory AgentsAntineoplastic AgentsCohort StudiesDrug Therapy, CombinationEnzyme-Linked Immunosorbent AssayFemaleFollow-Up StudiesHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMaximum Tolerated DoseMethylprednisoloneMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAnti-Inflammatory AgentsAntineoplastic AgentsMethylprednisoloneRituximab

Identifiers

PMID19693094
PMCPMC2761991
OpenAlexW2029903885

What OpenQuestion holds

Textmetadata
LicenceTDM
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.