Evidence map›Paper›PMID 30668890›Full record

Trial reportCancer2019

Phase 1/2 study of DFP-10917 administered by continuous intravenous infusion in patients with recurrent or refractory acute myeloid leukemia.

Hagop M Kantarjian, Elias J Jabbour, Guillermo Garcia-Manero, Tapan M Kadia, Courtney D DiNardo, Naval G Daver, Gautam Borthakur, Nitin Jain, Jane B Waukau, Monica I Kwari and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01702155 (A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.9field-weighted citation impact, top 9% 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.

NCT01702155 phase1 / phase2completednot on this map

A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia

TypeinterventionalSponsorDelta-Fly Pharma, Inc.Ran2012 to 2017Enrolled69ConditionsAcute Myeloid Leukemia, Acute Lymphocytic LeukemiaArmsDFP-10917
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
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

16 authors at 3 institutions in 2 countries.

Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Elias J JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4465-6119
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-3631-2482
Tapan M KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9892-9832
Courtney D DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-9003-0390
Naval G DaverDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-7103-373X
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jane B WaukauDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Monica I KwariDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Barry D AndersonTheradex Oncology, Princeton, New Jersey.
Kenzo IizukaDelta-Fly Pharma Inc, Tokushima, Japan.
Cheng JinDelta-Fly Pharma Inc, Tokushima, Japan.
Chun ZhangDelta-Fly Pharma Inc, Tokushima, Japan.
William K PlunkettDepartment of Experimental Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center · USTokushima Bunri University · JPTheradex Oncology (United States) · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundDFP-10917, a deoxycytidine nucleoside analogue, has a unique mechanism of action resulting in leukemic cell death when administered for prolonged periods at low doses. The current phase 1/2 study investigated the safety, maximum tolerated dose, and evidence of antileukemic activity for DFP-10917 administered by 7-day or 14-day continuous intravenous infusion in patients with recurrent or refractory acute myeloid leukemia (AML).

methodsIn the phase 1 dose escalation portion of the study, patients were administered DFP-10917 by 7-day continuous intravenous infusion plus 21-day rest (stage 1) or 14-day continuous intravenous infusion plus 14-day rest (stage 2). The primary objectives of phase 1 were to determine the maximum tolerated dose, the phase 2 dose, and the dose-limiting toxicities (DLTs) of DFP-10917. The primary objectives of phase 2 were to evaluate the overall response rate of DFP-10917 using complete response (CR), CR without platelet recovery (CRp), CR with incomplete blood count recovery (CRi) or partial response.

resultsIn stage 1 of phase 1 (4-35 mg/m

conclusionsDFP-10917 as a 14-day continuous intravenous infusion at a dose of 6 mg/m

Indexed as

AdultAgedAged, 80 and overDeoxycytidineDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansInfusions, IntravenousKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisDeoxycytidineDFP-10917acute myeloid leukemia (AML)deoxycytidinerecurrent AMLrefractory AMLsapacitabine

Identifiers

PMID30668890
PMCPMC12704656
OpenAlexW2914617448

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.