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Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by (Responsible Party):
Beth Christian, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00989586
First received: October 2, 2009
Last updated: December 8, 2016
Last verified: December 2016
Results First Received: April 28, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: milatuzumab
Biological: veltuzumab
Procedure: Correlative/Special Studies
Procedure: Quantitative T-, B-, and NK cell subsets
Procedure: Pharmacokinetics
Procedure: Human Anti-Human Antibodies
Biological: veltuzumab and milatuzumab

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Phase I

Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.

milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with

Phase II

Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.

veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks


Participant Flow:   Overall Study
    Phase I   Phase II
STARTED   18   17 
COMPLETED   18   17 
NOT COMPLETED   0   0 



  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.
Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.

Reporting Groups
  Description
Phase I

Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.

milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with

Phase II

Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.

veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks

Total Total of all reporting groups

Baseline Measures
   Phase I   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   17   35 
Age 
[Units: Years]
Median (Full Range)
 65 
 (44 to 81) 
 63 
 (39 to 82) 
 63 
 (39 to 82) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  27.8%      7  41.2%      12  34.3% 
Male      13  72.2%      10  58.8%      23  65.7% 
Region of Enrollment 
[Units: Patients]
     
United States   18   17   35 


  Outcome Measures
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1.  Primary:   Dose Limiting Toxicity (DLT) for Phase I Patients   [ Time Frame: up to 2 years ]

2.  Primary:   Maximum Tolerated Dose (MTD)for Phase I Patients   [ Time Frame: up to 2 years ]

3.  Primary:   Overall Objective Response Rate   [ Time Frame: Up to 2 years ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: up to 2 years ]

5.  Secondary:   Fcγ-receptor Polymorphism Response to Treatment   [ Time Frame: up to 2 years ]

6.  Secondary:   Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry   [ Time Frame: up to 1 year ]

7.  Secondary:   Access Pharmacokinetics Through AUC0–∞ (Area Under Curve)   [ Time Frame: 0, 24, 48, 72, 96 and 120 hours post-does ]

8.  Secondary:   Access Pharmacokinetics Through Cmax   [ Time Frame: 0, 24, 48, 72, 96 and 120 hours post-dose ]

9.  Secondary:   Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA)   [ Time Frame: up to 36 weeks ]


  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: Beth Christian
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-8858
e-mail: beth.christian@osumc.edu


Publications of Results:

Responsible Party: Beth Christian, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00989586     History of Changes
Other Study ID Numbers: OSU-09024
NCI-2011-03150 ( Registry Identifier: Clinical Trial Reporting Program )
Study First Received: October 2, 2009
Results First Received: April 28, 2016
Last Updated: December 8, 2016