Nivolumab and Pomalidomide in Treating Patients With Relapsed or Refractory Central Nervous System Diffuse Large B Cell Lymphoma or Primary Vitreoretinal Diffuse Large B Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03798314|
Recruitment Status : Active, not recruiting
First Posted : January 9, 2019
Last Update Posted : February 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Nervous System Lymphoma Recurrent Primary Vitreoretinal DLBCL Refractory Nervous System Lymphoma Refractory Primary Vitreoretinal DLBCL||Biological: Nivolumab Drug: Pomalidomide||Phase 1|
I. To establish the maximum tolerated dose (MTD) of pomalidomide which can be safely combined with the fixed dose schedule of nivolumab in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and primary vitreoretinal lymphoma (PVRL). (Phase I)
I. To evaluate the overall response rate (ORR) and progression free survival (PFS) of nivolumab and pomalidomide combination in patients with relapsed/refractory PCNSL and PVRL.
OUTLINE: This is dose-escalation study of pomalidomide.
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and pomalidomide orally (PO) on days 1-14. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 weeks, then every 3 months for 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial for Evaluation of Nivolumab and Pomalidomide Combination for Relapsed/Refractory Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma|
|Actual Study Start Date :||January 30, 2019|
|Estimated Primary Completion Date :||February 4, 2022|
|Estimated Study Completion Date :||February 4, 2023|
Experimental: Treatment (nivolumab and pomalidomide)
Patients receive nivolumab IV over 30 minutes on day 1 and pomalidomide PO on days 1-14. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity.
- Maximum-tolerated dose (MTD) of pomalidomide [ Time Frame: Up to 28 days ]The MTD in this study will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
- Incidence of adverse events [ Time Frame: Up to 12 weeks following end of treatment. ]Will be evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 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.
- Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment [ Time Frame: Up to 12 weeks following end of treatment ]The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
- Overall response rate (ORR) [ Time Frame: Up to 4 years ]Will be estimated by the number of patients with an objective status of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
- Progression-free survival (PFS) [ Time Frame: From registration to progression or death due to primary central nervous system lymphoma (PCNSL) or primary vitreoretinal lymphoma (PVRL), assessed up to 4 years ]Will be estimated using the method of Kaplan-Meier.
- Incidence of adverse events [ Time Frame: Up to 12 weeks following treatment ]Will be assessed by CTCAE version 5.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
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): NCT03798314
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Han Tun||Mayo Clinic|