NCT00834093|CompletedPhase 2ResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
18
1 country
2
Study Start
April 2009
Actual (reported)Primary Completion
March 2012
Actual (reported)Study Completion
February 2017
Actual (reported)The purpose of this research study is to determine how effective and how safe it is to give an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the participant's body. This is phase II study with the aim of establishing a baseline of efficacy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2009
Actual (reported)February 3, 2009
Actual (reported)April 2009
Actual (reported)March 2012
Actual (reported)February 2017
Actual (reported)June 28, 2023
Actual (reported)Best Overall Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Restaging scans were performed every 8 weeks on treatment up to 20 weeks.
Time to Progression (TTP)
Restaging scans were performed every 8 weeks until PD. Follow-up duration was up to 92 months.
Number of Participants With Grade 1-2 Fatigue Adverse Events," as Accurate and Appropriate
Adverse events were assessed after each infusion treatment. Treatment duration was up to 66 months.
Overall Survival (OS)
Participants were followed for survival per institutional practice until death or lost-to-follow-up. Follow-up duration was up to 92 months.
Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Huang J, Fogg M, Wirth LJ, Daley H, Ritz J, Posner MR, Wang FC, Lorch JH. Epstein-Barr virus-specific adoptive immunotherapy for recurrent, metastatic nasopharyngeal carcinoma. Cancer. 2017 Jul 15;123(14):2642-2650. doi: 10.1002/cncr.30541. Epub 2017 Feb 21.
The number of evaluable participants did not meet protocol objectives (n=13 versus target n=18).
Glenn Hanna, MD
Dana-Farber Cancer Institute
18 participants (actual enrollment reported by the registry).
First Submitted
February 2, 2009
First Posted
February 3, 2009
Study Start
April 2009
Actual (reported)The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma
Contact the study team to confirm eligibility.
Primary Completion
March 2012
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
June 28, 2023
Results First Posted
June 28, 2023
Record last verified: 2023-06
There are no plans to share IPD. Cumulative results will be posted and published.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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