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A Phase 2 Multicenter, Investigator Initiated Study of Oral Ruxolitinib Phosphate for the Treatment of Relapsed or Refractory Diffuse Large B-cell and Peripheral T-cell Non-Hodgkin Lymphoma

Phase 2
19 Years
Open (Enrolling)
Peripheral T-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma

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Trial Information

A Phase 2 Multicenter, Investigator Initiated Study of Oral Ruxolitinib Phosphate for the Treatment of Relapsed or Refractory Diffuse Large B-cell and Peripheral T-cell Non-Hodgkin Lymphoma


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.


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.


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-κB, BCR, PI3K/AKT, and mTOR pathways.

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


Patients receive ruxolitinib phosphate (oral JAK inhibitor INCB18424) orally (PO) twice
daily (BID). 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.

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

- Subjects must be willing and able to have a fresh tumor biopsy prior to start of
study treatment for research evaluations

- 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

- 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 >= 60mL/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 through follow-up

- Males must agree to take appropriate precautions to avoid fathering a child from
screening through follow-up

- Able to comprehend and willing to sign an Informed Consent Form (ICF)

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients achieving overall response rate

Outcome Time Frame:

after 24 weeks

Safety Issue:


Principal Investigator

Julie M Vose, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

August 2025

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral



University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
University of Texas, MD Anderson Cancer CenterHouston, Texas  77030