Evidence map›Paper›PMID 23810245›Full record

Trial reportClinical lymphoma, myeloma & leukemia2013

Phase I-II clinical trial of oxaliplatin, fludarabine, cytarabine, and rituximab therapy in aggressive relapsed/refractory chronic lymphocytic leukemia or Richter syndrome.

Apostolia M Tsimberidou, William G Wierda, Sijin Wen, William Plunkett, Susan O'Brien, Thomas J Kipps, Jeffrey A Jones, Xavier Badoux, Hagop Kantarjian, Michael J Keating and 1 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical lymphoma, myeloma & leukemia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 5% 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

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Pooled it
  2. Chronic lymphocytic leukemia/small lymphocytic lymphoma, version 1.2015.Journal of the National Comprehensive Cancer Network : JNCCN · 2015
    Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Richter transformation-is there light at the end of this tunnel?Hematology. American Society of Hematology. Education Program · 2023
    Review
  15. Review
  16. Review
  17. Treatment of Richter's syndrome.Hematology. American Society of Hematology. Education Program · 2022
    Review
  18. Review
  19. The Pt(International journal of molecular sciences · 2022
    Article
  20. 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

11 authors at 3 institutions in 1 country.

Apostolia M TsimberidouDepartment of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: atsimber@mdanderson.org.
William G Wierda
Sijin Wen
William Plunkett
Susan O'Brien
Thomas J Kipps
Jeffrey A Jones
Xavier Badoux
Hagop Kantarjian
Michael J Keating
Chronic Lymphocytic Leukemia Research Consortium
The University of Texas MD Anderson Cancer Center · USThe Ohio State University · USUniversity of California, San Diego · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
NCI NIH HHS P01 CA081534NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundTo improve outcomes of patients with Richter syndrome (RS) and relapsed/refractory chronic lymphocytic leukemia (CLL), we modified the OFAR1 regimen (oxaliplatin and cytarabine doses of the oxaliplatin, fludarabine, cytarabine, and rituximab) for this phase I-II study (OFAR2). PATIENTS AND

methodsOFAR2 consisted of oxaliplatin at 30 mg/m(2) on days 1 to 4, fludarabine at 30 mg/m(2), cytarabine at 0.5 g/m(2), rituximab at 375 mg/m(2) on day 3, and pegfilgrastim at 6 mg on day 6. Fludarabine and cytarabine were given on days 2 and 3 (cohort 1), days 2 to 4 (cohort 2), or days 2 to 5 (cohort 3) every 4 weeks. Phase II followed the "3 + 3" design of phase I.

resultsThe 102 patients (CLL, 67; RS, 35) treated had heavily pretreated high-risk disease. Twelve patients were treated in phase I; cohort 2 was the phase II recommended dose. The most common toxicities were hematologic. Response rates (phase II) were 38.7% for RS (complete response [CR], 6.5%) and 50.8% for relapsed/refractory CLL (CR, 4.6%). The median survival durations were 6.6 (RS) and 20.6 (CLL) months. Among 9 patients who underwent allogeneic stem cell transplantation (SCT) as post-remission therapy, none has died (median follow-up, 15.9 months).

conclusionOFAR2 had significant antileukemic activity in RS and relapsed/refractory CLL. Patients undergoing SCT as post-remission therapy had favorable outcomes.

Indexed as

Antibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCytarabineDisease ProgressionHematopoietic Stem Cell TransplantationHumansLeukemia, Lymphocytic, Chronic, B-CellNeoplasm StagingOrganoplatinum CompoundsOxaliplatinRecurrenceRituximabTransplantation, HomologousTreatment OutcomeVidarabineAntibodies, Monoclonal, Murine-DerivedCytarabinefludarabineOrganoplatinum CompoundsOxaliplatinRituximabVidarabineOFARRefractory CLLRichter syndromeSCTTherapy

Identifiers

PMID23810245
PMCPMC4180513
OpenAlexW2167282010

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.