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NCT01431209

Ruxolitinib Phosphate to Treat Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Stem Cell Transplant

Completed Phase 2 Results posted Last updated 5 October 2023
What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Diffuse Large B-Cell Lymphoma in 71 participants. Completed in 26 May 2021.

Timeline
12 August 2011
Primary endpoint
28 October 2020
26 May 2021

Quick facts

Lead sponsorUniversity of Nebraska
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment71
Start date12 August 2011
Primary completion28 October 2020
Estimated completion26 May 2021
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska

Who can join

18 and older, any sex, with Recurrent Diffuse Large B-Cell Lymphoma or Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate Primary · 24 weeks

Number of patients achieving overall response rate

GroupValue95% CI
Diffuse Large B-cell Lymphoma (DLBCL)1
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)1
Diffuse Large B-cell Lymphoma (DLBCL)3
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)1
Diffuse Large B-cell Lymphoma (DLBCL)5
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)3
Diffuse Large B-cell Lymphoma (DLBCL)34
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)7
Overall Survival (OS) Secondary · From the date of start of treatment to date of death due to any cause, assessed up to 60 months

The Kaplan-Meier method will be used to estimate the median OS time and its 95% CI.

GroupValue95% CI
Diffuse Large B-cell Lymphoma (DLBCL)5.93.3 – 14.3
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)6.93.8 – 24.3
Progression-free Survival Secondary · From the date of start of treatment to the date of event defined as the first documented progression or death due to any cause, assessed up to 60 months.

The Kaplan-Meier method will be used to estimate the median PFS time and its 95% CI.

GroupValue95% CI
Diffuse Large B-cell Lymphoma (DLBCL)1.81.1 – 1.8
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)2.20.9 – 4.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Event monitoring should be continued for at least 30 days following the last dose of study treatment. Since this treatment trial was for relapsed or refractory disease in subjects, subjects were allowed to continue study treatment as long as they received benefit and met not reason for study discontinuation. The last subject remained on treatment for 7 1/2 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diffuse Large B-cell Lymphoma (DLBCL)
Serious: 22/47 (47%)
Deaths: 31/47
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
Serious: 7/13 (54%)
Deaths: 11/13

Serious adverse events (58 terms)

ReactionSystemDiffuse Large B-cell Lymph…Peripheral T-cell Non-Hodg…
FeverGeneral disorders
sepsisInfections and infestations
thromboembolic eventVascular disorders
AnemiaBlood and lymphatic system disorders
lung infectionInfections and infestations
hypoxiaRespiratory, thoracic and mediastinal disorders
Acute kidney injuryInjury, poisoning and procedural complications
dyspneaRespiratory, thoracic and mediastinal disorders
hypercalcemiaMetabolism and nutrition disorders
ileusGastrointestinal disorders
respiratory failureRespiratory, thoracic and mediastinal disorders
sinus tachycardiaCardiac disorders
Infections and infestiations - OtherInfections and infestations
Respiratory disorder- otherRespiratory, thoracic and mediastinal disorders
coughRespiratory, thoracic and mediastinal disorders
FallInjury, poisoning and procedural complications
fatigueGeneral disorders
febrile neutropeniaBlood and lymphatic system disorders
hypernatremiaMetabolism and nutrition disorders
hyponatremiaMetabolism and nutrition disorders
hypophosphatemiaMetabolism and nutrition disorders
hypotensionVascular disorders
Injury, procedural - OtherInjury, poisoning and procedural complications
Musculoskeletal, OtherMusculoskeletal and connective tissue disorders
pleuritc painRespiratory, thoracic and mediastinal disorders
Other adverse events (23 terms — click to expand)

ReactionSystemDiffuse Large B-cell Lymph…Peripheral T-cell Non-Hodg…
anemiaBlood and lymphatic system disorders
platelet count decreasedInvestigations
lymphocyte count decreasedInvestigations
dyspneaRespiratory, thoracic and mediastinal disorders
neutrophil count decreasedInvestigations
sepsisInfections and infestations
fatigueGeneral disorders
hyponatremiaMetabolism and nutrition disorders
feverGeneral disorders
hypercalcemiaMetabolism and nutrition disorders
hypophosphatemiaMetabolism and nutrition disorders
hypotensionVascular disorders
Respiratory, thoracic and mediastinal disorder - OtherRespiratory, thoracic and mediastinal disorders
apneaRespiratory, thoracic and mediastinal disorders
FallInjury, poisoning and procedural complications
febrile neutropeniaBlood and lymphatic system disorders
lung infectionRespiratory, thoracic and mediastinal disorders
malaiseGeneral disorders
Musculoskeletal, OtherMusculoskeletal and connective tissue disorders
nauseaGastrointestinal disorders
pneumonitisRespiratory, thoracic and mediastinal disorders
pruritisSkin and subcutaneous tissue disorders
skin ulcerationSkin and subcutaneous tissue disorders

Most-reported serious reactions: Fever, sepsis, thromboembolic event, Anemia, lung infection, hypoxia, Acute kidney injury, dyspnea.

Data from ClinicalTrials.gov NCT01431209 adverse events section.

Sponsor's own description

This phase II trial studies how well ruxolitinib phosphate works in treating patients with diffuse large B-cell or peripheral T-cell non-Hodgkin lymphoma that has returned (relapsed) or that does not respond to treatment (refractory) after donor stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel drug targets for personalized precision medicine in relapsed/refractory diffuse large B-cell lymphoma: a comprehensive review.
    Camicia R, Winkler HC, Hassa PO. · · 2015 · cited 137× · PMID 26654227 · DOI 10.1186/s12943-015-0474-2
  2. New agents and regimens for diffuse large B cell lymphoma.
    Wang L, Li LR, Young KH. · · 2020 · cited 109× · PMID 33317571 · DOI 10.1186/s13045-020-01011-z
  3. JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
    Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
  4. The Role of Janus Kinase Signaling in Graft-Versus-Host Disease and Graft Versus Leukemia.
    Schroeder MA, Choi J, Staser K, DiPersio JF. · · 2018 · cited 82× · PMID 29289756 · DOI 10.1016/j.bbmt.2017.12.797
  5. A Review of New Findings in Adult T-cell Leukemia-Lymphoma: A Focus on Current and Emerging Treatment Strategies.
    Hermine O, Ramos JC, Tobinai K. · · 2018 · cited 61× · PMID 29411267 · DOI 10.1007/s12325-018-0658-4
  6. The landscape of new drugs in lymphoma.
    Younes A, Ansell S, Fowler N, Wilson W, et al · · 2017 · cited 59× · PMID 28031560 · DOI 10.1038/nrclinonc.2016.205
  7. STAT3 Activation and Oncogenesis in Lymphoma.
    Zhu F, Wang KB, Rui L. · · 2019 · cited 55× · PMID 31861597 · DOI 10.3390/cancers12010019
  8. Clinical implications of phosphorylated STAT3 expression in De Novo diffuse large B-cell lymphoma.
    Ok CY, Chen J, Xu-Monette ZY, Tzankov A, et al · · 2014 · cited 54× · PMID 25124685 · DOI 10.1158/1078-0432.ccr-14-0683

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for Recurrent Diffuse Large B-Cell Lymphoma

Currently open trials in the same condition.

Other University of Nebraska trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01431209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing