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Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma

This study has been terminated.
(closed to enrollment due to slow patient accrual)
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01147393
First received: June 16, 2010
Last updated: April 27, 2017
Last verified: April 2017
Results First Received: February 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Follicular Lymphoma
Interventions: Drug: 90Y-epratuzumab tetraxetan
Biological: veltuzumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subjects

two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.

90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.

veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2.


Participant Flow for 2 periods

Period 1:   Dose Level 1
    All Subjects
STARTED   3 
COMPLETED   1 
NOT COMPLETED   2 
Dose limiting Toxicity                2 

Period 2:   Dose Level -1
    All Subjects
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Dose Limited Toxicity                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Subjects

two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.

90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.

veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2.


Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age, Customized 
[Units: Participants]
Count of Participants
 
Patients by Age   
60-69 Years of Age      3  75.0% 
70-79 Years of Age      1  25.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  75.0% 
Male      1  25.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Determine the Maximum Tolerated 90Y Dose   [ Time Frame: ]

2.  Primary:   Dose-limiting Toxicity   [ Time Frame: ]

3.  Primary:   Safety   [ Time Frame: ]

4.  Primary:   The Primary Objective of the Phase II Portion of the Study is to Determine the Anti-tumor Efficacy, as Measured by Response Rate, of Fractionated 90Y-epratutumab IgG Given in Combination With Veltuzumab Anti-CD20 IgG Therapy   [ Time Frame: ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter Martin, MD
Organization: Weill Cornell Medicine
phone: 646.962.2064
e-mail: amr2017@med.cornell.edu



Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01147393     History of Changes
Other Study ID Numbers: 1001010838
Study First Received: June 16, 2010
Results First Received: February 23, 2017
Last Updated: April 27, 2017