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Trial record 54 of 1147 for:    "Follicular lymphoma"

Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)

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ClinicalTrials.gov Identifier: NCT01370694
Recruitment Status : Terminated (The study was terminated for business reasons.)
First Posted : June 10, 2011
Results First Posted : November 25, 2015
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Follicular Lymphoma
Interventions Drug: MK-8808
Drug: cyclophosphamide
Drug: vincristine
Drug: prednisolone
Enrollment 7
Recruitment Details The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 on 18 March 2014, but could continue to receive maintenance therapy with rituximab per standard of care.
Pre-assignment Details  
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Period Title: Overall Study
Started 7
Completed 1
Not Completed 6
Reason Not Completed
Switched to rituximab             4
Progressive disease             2
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
56.1  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
1.Primary Outcome
Title Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
Hide Description An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame From first dose of combination therapy up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one dose of any study drug.
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description:
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
6
2.Primary Outcome
Title Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy
Hide Description An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame From first dose of single agent MK-8808 up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description:
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP
Hide Description Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.
Time Frame Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not done due to early termination of the study.
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description:
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy
Hide Description Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.
Time Frame Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description:
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP
Hide Description Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
Time Frame Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not done due to early termination of the study.
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description:
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance
Hide Description Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
Time Frame Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description:
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Clinical Response of Tumor to MK-8808/CVP Combination Therapy
Hide Description The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description:
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
PR 6
CR 0
CRu 0
Time Frame Up to 30 days after last dose of CVP therapy (up to 28 weeks)
Adverse Event Reporting Description Adverse events were not collected for participants who were switched to MabThera.
 
Arm/Group Title MK-8808 Combination Therapy
Hide Arm/Group Description Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
All-Cause Mortality
MK-8808 Combination Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-8808 Combination Therapy
Affected / at Risk (%) # Events
Total   1/7 (14.29%)    
Injury, poisoning and procedural complications   
Femoral neck fracture  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MK-8808 Combination Therapy
Affected / at Risk (%) # Events
Total   6/7 (85.71%)    
Blood and lymphatic system disorders   
Anaemia  1  1/7 (14.29%)  1
Cardiac disorders   
Tachycardia  1  1/7 (14.29%)  1
Eye disorders   
Blepharitis  1  1/7 (14.29%)  1
Immune system disorders   
Hypersensitivity  1  1/7 (14.29%)  1
Infections and infestations   
Bronchitis  1  1/7 (14.29%)  1
Gastroenteritis  1  1/7 (14.29%)  1
Pharyngotonsillitis  1  1/7 (14.29%)  1
Skin infection  1  1/7 (14.29%)  1
Upper respiratory tract infection  1  1/7 (14.29%)  1
Investigations   
Alanine aminotransferase increased  1  1/7 (14.29%)  2
Neutrophil count decreased  1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Hypercreatininaemia  1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
The study was terminated for business reasons. Not all planned analyses were performed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01370694     History of Changes
Other Study ID Numbers: 8808-001
2011-000386-13 ( EudraCT Number )
First Submitted: May 18, 2011
First Posted: June 10, 2011
Results First Submitted: October 23, 2015
Results First Posted: November 25, 2015
Last Update Posted: March 15, 2019