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

NCT01431209 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 0283-11-FBNCI-2011-02733P30CA036727
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Number of patients achieving overall response rate

  24 weeks

Secondary Outcomes (2)

• Overall Survival (OS)

  From the date of start of treatment to date of death due to any cause, assessed up to 60 months

• Progression-free Survival

  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.

Study Arms (1)

Treatment (ruxolitinib phosphate)

EXPERIMENTAL

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

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ruxolitinib phosphate)

Ruxolitinib Phosphate DRUG

Given PO

Also known as: INCB-18424 Phosphate, Jakafi

Treatment (ruxolitinib phosphate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• 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.

  PMID: 33942298 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Julie M. Vose
• Organization: University of Nebraska Medical Center

jmvose@unmc.edu

402-559-3848

Study Officials

• Julie M Vose, MD, MBA

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2011
• First Posted: September 9, 2011
• Study Start: August 12, 2011
• Primary Completion: October 28, 2020
• Study Completion: May 26, 2021
• Last Updated: October 5, 2023
• Results First Posted: June 24, 2021

Record last verified: 2023-09

Locations

US (3)