Evidence map›Paper›PMID 30340199›Full record

ArticleLeukemia research2018

A phase I clinical trial of ruxolitinib in combination with nilotinib in chronic myeloid leukemia patients with molecular evidence of disease.

Kendra Sweet, Lori Hazlehurst, Eva Sahakian, John Powers, Lisa Nodzon, Fadi Kayali, Kelly Hyland, Ashley Nelson, Javier Pinilla-Ibarz

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Leukemia research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01702064 (A Phase I Study of Ruxolitinib in Combination With Nilotinib in CML Patients With Evidence of Molecular Disease), which is not on this map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing 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.

NCT01702064 phase1completednot on this map

A Phase I Study of Ruxolitinib in Combination With Nilotinib in CML Patients With Evidence of Molecular Disease

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2013 to 2019Enrolled11ConditionsChronic Phase Chronic Myeloid LeukemiaArmsNilotinib, Ruxolitinib
3 · Its place in the literature

Who cites it

34 citing papers in PubMed.

  1. Review
  2. Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026
    Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Future Directions in Chronic Phase CML Treatment.Current hematologic malignancy reports · 2021
    Review
  18. Review
  19. Review
  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

9 authors.

Kendra SweetH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States. Electronic address: Kendra.Sweet@moffitt.org.
Lori HazlehurstH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States.
Eva SahakianH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States.
John PowersH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States.
Lisa NodzonH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States.
Fadi KayaliFlorida Cancer Specialists, Lakewood Ranch/Sarasota, FL and Florida State University, Tallahassee, FL, United States.
Kelly HylandH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States; Department of Psychology, University of South Florida, Tampa, FL, United States.
Ashley NelsonH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States; Department of Psychology, University of South Florida, Tampa, FL, United States.
Javier Pinilla-IbarzH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States.

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

purposePreclinical evidence indicates that the bone marrow microenvironment provides a protective niche for leukemic stem cells, allowing them to evade the effects of BCR-ABL tyrosine kinase inhibitors (TKIs), but that targeting of the JAK-STAT pathway with the JAK2 inhibitor ruxolitinib increases TKI-induced apoptosis. A phase I clinical trial (NCT01702064) investigated the tolerability and safety of treating chronic-phase chronic myeloid leukemia patients with ruxolitinib in combination with the BCR-ABL TKI nilotinib and explored initial efficacy evidence. EXPERIMENTAL

designEleven patients already treated with single-agent nilotinib (300-400 mg twice daily) commenced combination therapy, and molecular responses were evaluated after 6 months. Three ruxolitinib dose cohorts were studied: 5 mg, 10 mg, and 15 mg twice daily.

resultsOne patient experienced a grade 3/4 adverse event (hypophosphatemia) and 36% of patients experienced grade 1/2 anemia. Of 10 patients who were evaluable for responses, 40% had undetectable BCR-ABL transcripts, as measured by quantitative RT-PCR after 6 months. Plasma inhibitory assay results revealed a decrease in phospho-STAT3 levels after treatment with ruxolitinib. The recommended phase 2 dose of ruxolitinib was 15 mg BID.

conclusionsOverall, this combination was safe and well-tolerated, and the molecular responses were encouraging, thereby warranting further investigation in a phase 2 trial.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedNitrilesPyrazolesPyrimidinesnilotinibNitrilesPyrazolesPyrimidinesruxolitinibChronic myeloid leukemiaMolecular diseaseNilotinibRuxolitinib

Identifiers

PMID30340199
PMCPMC7787269

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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.