Ruxolitinib Phosphate in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Donor Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT01431209|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2011
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Laboratory Biomarker Analysis Drug: Ruxolitinib Phosphate||Phase 2|
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).
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-kB, 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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
- Number of patients achieving overall response rate [ Time Frame: 24 weeks ]
- Duration of response [ Time Frame: From the date of complete or partial remission documented to date of recurrence/progression, death due to any cause, or lost to follow-up, assessed up to 5 years ]The Kaplan-Meier method will be used to estimate the median duration of response and its 95% confidence interval (CI).
- Incidence of treatment-emergent adverse events (new or worsening from baseline) [ Time Frame: Up to 30 days after study treatment has ended ]Summarized by severity and type according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
- Overall survival (OS) [ Time Frame: From the date of start of treatment to date of death due to any cause, assessed up to 5 years ]The Kaplan-Meier method will be used to estimate the median OS time and its 95% CI.
- Progression-free survival [ 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 5 years ]The Kaplan-Meier method will be used to estimate PFS and its 95% CI.
- Alterations in GEP signatures as well as biomarker immunophenotypic changes related to JAK2/STAT3, NF-κB, BCR, PI3K/AKT, and mTOR pathways [ Time Frame: Up to 6 weeks post treatment ]Descriptive statistics will be used. Mean, standard deviation, median and range will be reported for markers pre- and post-treatment as well as for the marker changes between pre- and post-treatment. Paired t-test will be used to evaluate the marker changes between pre- and post-treatment. Spearman or Pearson correlation coefficients will be calculated to evaluate the correlations among markers. Logistic regression will be utilized to assess the effects of markers at baseline on response to therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431209
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Julie Vose||University of Nebraska|