Evidence map›Paper›PMID 19738118›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

5-year survival in patients with relapsed or refractory chronic lymphocytic leukemia in a randomized, phase III trial of fludarabine plus cyclophosphamide with or without oblimersen.

Susan O'Brien, Joseph O Moore, Thomas E Boyd, Loree M Larratt, Aleksander B Skotnicki, Benjamin Koziner, Asher A Chanan-Khan, John F Seymour, John Gribben, Loretta M Itri and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00024440 (Randomized Study Of Fludarabine And Cyclophosphamide With Or Without Genasense), which is not on this map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT00024440 phase3completednot on this map

Randomized Study Of Fludarabine And Cyclophosphamide With Or Without Genasense (Bcl-2 Antisense Oligonucleotide) In Subjects With Relapsed Or Refractory Chronic Lymphocytic Leukemia

TypeinterventionalSponsorGenta IncorporatedRan2001 to 2007ConditionsLeukemiaArmsfilgrastim, oblimersen sodium, cyclophosphamide, fludarabine phosphate
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 163 citations in OpenAlex.

  1. Pooled it
  2. Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026
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  12. The Role ofCancers · 2020
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1 more citing papers are in PubMed but not listed here.

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 4 institutions in 4 countries.

Susan O'BrienDivision of Hematology, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. sobrien@mdanderson.org
Joseph O Moore
Thomas E Boyd
Loree M Larratt
Aleksander B Skotnicki
Benjamin Koziner
Asher A Chanan-Khan
John F Seymour
John Gribben
Loretta M Itri
Kanti R Rai
Duke Medical Center · USJagiellonian University · PLUniversity of Melbourne · AUInstituto Argentino de Diagnóstico y Tratamiento · AR

Funding

Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
6 · The paper itself

Abstract

purposeA randomized trial of oblimersen plus fludarabine/cyclophosphamide (OBL-FC; n = 120) versus FC (n = 121) was conducted in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). The primary end point was met: the complete response (CR) rate, defined as complete or nodular partial response, was significantly greater with OBL-FC than with FC (17% v 7%; P = .025). Among patients with CR, response duration was significantly longer with OBL-FC than with FC (median not reached; > 36 months v 22 months; P = .03). Maximum benefit with OBL-FC, including a four-fold increase in CR rate and a survival benefit with 3 years of follow-up (hazard ratio, 0.53; P = .05), was observed in patients with fludarabine-sensitive disease. We evaluated long-term survival and poststudy CLL therapy among all randomly assigned patients.

methodsPoststudy CLL treatment information was collected. Patients were observed for survival for up to 5 years from the date of random assignment.

resultsPoststudy CLL treatment was balanced between arms. Intent-to-treat analysis of 5-year survival showed no significant between-treatment difference (hazard ratio, 0.87; P = .34). Among the greater than 40% of patients with complete or partial remission, a significant 5-year survival benefit was observed with OBL-FC (hazard ratio, 0.60; P = .038). Among patients with fludarabine-sensitive disease who had previously demonstrated maximum benefit with OBL-FC, the previously observed survival benefit improved: a 50% reduction in the risk of death was observed (P = .004).

conclusionIn relapsed/refractory CLL, OBL combined with FC offers patients who achieve complete or partial remission, as well as those who have fludarabine-sensitive disease, a significant survival benefit.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideFemaleHumansKaplan-Meier EstimateLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm Recurrence, LocalThionucleotidesVidarabineCyclophosphamidefludarabineoblimersenThionucleotidesVidarabine

Identifiers

PMID19738118
PMCPMC5321078
OpenAlexW2126322093

What OpenQuestion holds

Textmetadata
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.