CompletedNCT01431209Updated Oct 5, 2023Results posted

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

A Phase 2 interventional study of Laboratory Biomarker Analysis and Ruxolitinib Phosphate in Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by University of Nebraska. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 71
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVES:

I. Assess the overall response rate (ORR) of subjects with relapsed diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL) who are relapsed or refractory to front-line treatment and ineligible for stem cell transplantation or have recurrent disease after stem cell transplantation to oral ruxolitinib (ruxolitinib phosphate).

SECONDARY OBJECTIVES:

I. Evaluate safety of oral ruxolitinib in subjects with DLBCL and PTCL. II. Determine progression-free survival (PFS), duration of response, and overall response (OS) in subjects with DLBCL and PTCL.

TERTIARY OBJECTIVES:

I. Explore the relationship between responses to oral ruxolitinib and alterations in gene expression profiling (GEP) signatures as well as biomarker immunophenotypic changes related to JAK2/STAT3, NF-kB, PI3K/AKT, and mTOR pathways.

II. Evaluate potential effect of oral ruxolitinib exposure on JAK2/STAT3 pathway inhibition in serial tumor samples.

OUTLINE:

Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.

Conditions studied

Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

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In context

Lymphoma, Large B-Cell, Diffuse

1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.

This study's enrollment of 71 is above the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects must have histologically documented relapsed or refractory disease, with a diagnosis of one of the following lymphoid malignancies: diffuse large B-cell lymphoma, peripheral T-cell lymphoma (any subtype); subjects must have received at least one prior systemic chemotherapy and must have either received an autologous stem cell transplant, refused or been deemed ineligible for an autologous stem cell transplant
Subjects must be willing and able to have a fresh tumor biopsy prior to start of study treatment for research evaluations and cohort categorizing; Note: if insufficient fresh tissue is obtained to provide sub-classification for cohorts, then tissue material from a previous relapse biopsy and/or original diagnostic block may be requested to meet this criterion
Subjects must have measurable lesions (at least one target lesion measuring 2 cm in diameter) by computerized tomography (CT) scan, and/or measurable lymphoma cutaneous lesions of any size
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count (ANC) >= 1,000/mm\^3
Platelet count >= 75,000/mm\^3
Hemoglobin >= 8.0 g/dL
Serum creatinine =\< 2.0 g/dL or calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault method)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal (ULN) or =\< 5 x ULN if liver involved by lymphoma
Bilirubin \< 2.0 x ULN unless subject has Gilbert's disease, low-grade hemolysis, or liver involvement with lymphoma
At least 2 weeks since prior chemotherapy, biological therapy, radiation therapy, major surgery, other investigational, or anti-cancer therapy that is considered disease-directed and recovered from prior toxicities to grade 0-1 at least 2 weeks prior to investigational therapy
Females will be either postmenopausal for at least 1 year or surgically sterile for at least 3 months; OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy from screening until 3 months after their last dose of study medication
Males must agree to take appropriate precautions to avoid fathering a child from screening until 3 months after their last dose of study medication
Able to comprehend and willing to sign an informed consent form (ICF)

Exclusion criteria

Exclusion Criteria:

History of or active central nervous system (CNS) malignancy
Allogeneic stem cell transplant within the last 6 months, or active-graft-versus-host disease following allogeneic transplant, or subjects currently on immunosuppressive therapy following allogeneic transplant
Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician; subjects receiving antibiotics that are under control may be included in the study
Pregnant or breastfeeding women
Clinically symptomatic and uncontrolled cardiovascular disease
History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure, within the 6 months prior to study drug administration
Current or recent history (\< 21 days prior to start of treatment) of a clinically significant bacterial, viral, fungal, parasitic or mycobacterial infection
History of other malignancy, with the exception of squamous cell carcinoma of the skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or other malignancies that have been in remission for at least 3 years
Presence of a malabsorption syndrome possibly affecting drug absorption (e.g., Crohn's disease or chronic pancreatitis)
Any prior or concomitant use of another JAK inhibitor
Known active hepatitis B or C, or human immunodeficiency virus (HIV) infection
Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 71 participants (actual)

Study arms

Experimental
Treatment (ruxolitinib phosphate)
Patients receive ruxolitinib phosphate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis · Drug: Ruxolitinib Phosphate

Interventions

OtherLaboratory Biomarker Analysis
Correlative studies
DrugRuxolitinib Phosphate
Given PO
Also known as: INCB-18424 Phosphate, Jakafi

What researchers measure

Primary outcomes

Overall Response Rate
Number of patients achieving overall response rate
Time frame: 24 weeks

Secondary outcomes

Overall Survival (OS)
The Kaplan-Meier method will be used to estimate the median OS time and its 95% CI.
Time frame: From the date of start of treatment to date of death due to any cause, assessed up to 60 months
Progression-free Survival
The Kaplan-Meier method will be used to estimate the median PFS time and its 95% CI.
Time frame: 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.

Results

Posted Jun 24, 2021

Participant flow

Evaluable population - Subjects who had completed 2 cycles of therapy with response assessments or progressed before the evaluation of the primary endpoint. Primary endpoint The primary objective of the study is to evaluate subject overall response rate (ORR) after 6 cycles for each of the subject cohorts. The description provided in this section includes the primary analyses for the primary objective.

Participant flow — Overall Study
Milestone	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
Started	47	13
Completed	43	12
Not completed	4	1

Outcome measures

PrimaryOverall Response Rate

Number of patients achieving overall response rate

Time frame:: 24 weeks
Reported as:: Count of participants · Participants

Overall Response Rate
Participants	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
Complete Response	1	1
Partial Response	3	1
Stable disease	5	3
Progressive disease	34	7
Not assessed	4	1

SecondaryOverall Survival (OS)

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

Time frame:: From the date of start of treatment to date of death due to any cause, assessed up to 60 months
Reported as:: Median · Months

Overall Survival (OS)
Months	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
Overall Survival (OS)	5.9 (3.3 to 14.3)	6.9 (3.8 to 24.3)

SecondaryProgression-free Survival

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

Time frame:: 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.
Reported as:: Median · Months

Progression-free Survival
Months	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
Progression-free Survival	1.8 (1.1 to 1.8)	2.2 (0.9 to 4.6)

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Diffuse Large B-cell Lymphoma (DLBCL)	31/47 (66%)	22/47 (46.8%)	43/47 (91.5%)
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)	11/13 (84.6%)	7/13 (53.8%)	12/13 (92.3%)

Most frequent serious events

Showing 10 of 58

Most frequent serious events
Event	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
FeverGeneral disorders	6/47	3/13
AnemiaBlood and lymphatic system disorders	1/47	2/13
sepsisInfections and infestations	4/47	1/13
Respiratory disorder- otherRespiratory, thoracic and mediastinal disorders	0/47	1/13
coughRespiratory, thoracic and mediastinal disorders	0/47	1/13
FallInjury, poisoning and procedural complications	0/47	1/13
fatigueGeneral disorders	0/47	1/13
febrile neutropeniaBlood and lymphatic system disorders	0/47	1/13
hypernatremiaMetabolism and nutrition disorders	0/47	1/13
hyponatremiaMetabolism and nutrition disorders	0/47	1/13

Most frequent other events

Showing 10 of 23

Most frequent other events
Event	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
anemiaBlood and lymphatic system disorders	11/47	1/13
fatigueGeneral disorders	2/47	2/13
hyponatremiaMetabolism and nutrition disorders	0/47	2/13
platelet count decreasedInvestigations	5/47	0/13
lymphocyte count decreasedInvestigations	4/47	1/13
dyspneaRespiratory, thoracic and mediastinal disorders	4/47	0/13
neutrophil count decreasedInvestigations	4/47	0/13
Respiratory, thoracic and mediastinal disorder - OtherRespiratory, thoracic and mediastinal disorders	0/47	1/13
apneaRespiratory, thoracic and mediastinal disorders	0/47	1/13
FallInjury, poisoning and procedural complications	1/47	1/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)	Total
Mean	64 ± 11	66 ± 13	65 ± 12

Sex: Female, Male
Sex: Female, Male(Participants)	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)	Total
Female	18	5	23
Male	29	8	37

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)	Total
American Indian or Alaska Native	1	0	1
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	1	1	2
White	40	12	52
More than one race	0	0	0
Unknown or Not Reported	3	0	3

Region of Enrollment
Region of Enrollment(participants)	Diffuse Large B-cell Lymphoma (DLBCL)	Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)	Total
United States	47	13	60

Study locations

3 sites

National Institutes of Health Clinical Center
Bethesda, Maryland 20892, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska 68198, United States

References and documents

Publications

Wang C, Althof PA, Bi C, Zhang W, Bouska AC, Tian T, Zhang X, Jiang N, Yu G, Cheng H, Iqbal J, Vose JM, Sanmann JN, Fu K. A novel MYC-non-IG fusion in refractory diffuse large B-cell lymphoma. Br J Haematol. 2021 Jun;193(5):1001-1004. doi: 10.1111/bjh.17255. Epub 2021 May 3. No abstract available. PubMed 33942298 ↗

Study documents

Protocol and statistical analysis plan · Feb 29, 2016

Documents are hosted by the registry — open the source record to download them.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2011 to primary completion in Oct 2020, 110 months.

Results were first posted in Jun 2021, 7 months after primary completion.

Of 198 non-industry phase 2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 97. This study's 110 months is above that.

Counting every sponsor, half of 249 studies reached it within 53 months; a quarter within 35 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 5, 2011
First posted: Sep 9, 2011
StartActual: Aug 12, 2011
Primary completionActual: Oct 28, 2020
CompletionActual: May 26, 2021
Results first posted: Jun 24, 2021
Last update: Oct 5, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01431209
Lead sponsor: University of Nebraska
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Sep 9, 2011
Start date: Aug 12, 2011
Primary completion: Oct 28, 2020
Completion: May 26, 2021
Results posted: Jun 24, 2021
Last update: Oct 5, 2023

Study contacts

Julie M Vose, MD, MBA

principal investigator · University of Nebraska

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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