Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma
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|ClinicalTrials.gov Identifier: NCT01722305|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma Central Nervous System Lymphoma Intraocular Lymphoma Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System Recurrent Adult Diffuse Large Cell Lymphoma Retinal Lymphoma||Drug: Dexamethasone Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Pomalidomide||Phase 1|
I. To establish the maximum tolerated dose (MTD) of pomalidomide in combination with dexamethasone in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) or primary vitreoretinal lymphoma (PVRL).
I. To evaluate the efficacy (overall response rate) and safety of pomalidomide in combination with dexamethasone in patients with PCNSL and PVRL lymphoma in an MTD expanded cohort.
II. To evaluate overall survival and progression free survival.
I. To study the pharmacokinetics of pomalidomide in the central nervous system. II. To identify the predictive biomarkers for responsiveness to pomalidomide.
OUTLINE: This is a dose-escalation study of pomalidomide.
Patients receive pomalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma|
|Actual Study Start Date :||April 8, 2013|
|Actual Primary Completion Date :||June 3, 2016|
|Estimated Study Completion Date :||June 2019|
Experimental: Treatment (pomalidomide, dexamethasone)
Patients receive pomalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Optional correlative studies
Other: Pharmacological Study
Optional correlative studies
- MTD of pomalidomide when given in combination with dexamethasone determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: 28 days ]The number and severity of all adverse events will be tabulated and summarized in this patient population both overall and by dose level. The grade 3+ adverse events will also be described and summarized in a similar fashion. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
- Incidence of adverse events, graded according to CTCAE 4.0 [ Time Frame: Up to 30 days post-treatment ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
- Overall response rate defined as number of patients with an objective status of complete response (CR), complete response/unconfirmed (Cru), or partial response (PR) divided by total number of evaluable patients [ Time Frame: Up to 2 years ]Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
- Overall survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 2 years ]The distribution of overall survival will be estimated using the method of Kaplan-Meier.
- Progression-free survival [ Time Frame: Time from registration to progression or death due to PCNSL or PVRL lymphoma, assessed up to 2 years ]The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
- Pharmacokinetics of pomalidomide in the CNS [ Time Frame: Up to day 22 of course 1 ]Based on pomalidomide levels in blood and CSF at different time points, area under curve will be determined.
- Predictive biomarkers for response to pomalidomide [ Time Frame: Up to day 21 of course 1 ]Correlation studies will be performed to identify predictive immune markers for response to pomalidomide. Immune cell counts and cytokine profile will be evaluated in blood and CSF at day 1 and day 21 of course 1. Values at each time point and changes after pomalidomide treatment will be both graphically and quantitatively summarized and explored. Wilcoxon rank sum test and Fisher's exact test will be utilized where appropriate to assess the relationships of these markers with response.
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): NCT01722305
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Massachusetts|
|Dana-Farber Harvard Cancer Center|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Han Tun||Mayo Clinic|