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MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00089076
Recruitment Status : Terminated
First Posted : August 5, 2004
Results First Posted : October 19, 2012
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Grade III Lymphomatoid Granulomatosis
B-cell Chronic Lymphocytic Leukemia
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: ipilimumab
Other: laboratory biomarker analysis
Enrollment 18
Recruitment Details

Participants were recruited from 2 medical clinics in the United States between August

> 2004 and September 2007.

Pre-assignment Details This was a phase I/II trial. A total of 18 participants were accrued, all to the phase I portion. This trial was terminated due to study design during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
Arm/Group Title MDX-010
Hide Arm/Group Description Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 18
Completed 8
Not Completed 10
Reason Not Completed
Alternate Therapy             1
Withdrawal by Subject             2
Progression             7
Arm/Group Title MDX-010
Hide Arm/Group Description Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
56
(37 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
6
  33.3%
Male
12
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
Disease Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Follicular grade 1 lymphoma 9
Follicular grade 2 lymphoma 5
Diffuse large B-cell lymphoma 3
Mantle cell lymphoma 1
Number of prior treatments  
Median (Full Range)
Unit of measure:  Treatments
Number Analyzed 18 participants
2
(1 to 4)
Dose Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
3 mg/kg first dose, then 1 mg/kg monthly x 3 doses 12
3 mg/kg monthly x 4 doses 6
1.Primary Outcome
Title Number of Overall Confirmed Responses(Complete Response or Partial Response)
Hide Description Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
Time Frame From registration to month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Time to Progression (Phase 2)
Hide Description The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time Frame From registration to progression (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
No participants proceeded to Phase 2 for evaluation.
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (Phase 2)
Hide Description The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Time Frame From registration to death (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
No participants proceeded to Phase 2 for evaluation.
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Response (Phase 2)
Hide Description Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.
Time Frame From response to progression (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
No participants proceeded to Phase 2 for evaluation.
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Mean Change in % of CD3+CD4+ for Marker HLA-DR+
Hide Description Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
Time Frame Before treatment to 1 month after therapy initiation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Mean (Standard Error)
Unit of Measure: percentage of change of CD3+CD4+
1.8  (1.2)
6.Secondary Outcome
Title Mean Change in % of CD3+CD4- for Marker HLA-DR+
Hide Description Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
Time Frame Before treatment to 1 month after therapy initiation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Mean (Standard Error)
Unit of Measure: percentage of change of CD3+CD4-
1.9  (2.0)
7.Secondary Outcome
Title Mean Change in % of CD3+CD4+ for Marker CD45RO+
Hide Description Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
Time Frame Before treatment to 1 month after therapy initiation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Mean (Standard Error)
Unit of Measure: percentage of change of CD3+CD4+
5.0  (1.5)
8.Secondary Outcome
Title Mean Change in % of CD3+CD4- for the Marker CD45RO+
Hide Description Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
Time Frame Before treatment to 1 month after therapy initiation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.
Arm/Group Title MDX-010
Hide Arm/Group Description:
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Mean (Standard Error)
Unit of Measure: percentage of change of CD3+CD4-
2.8  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MDX-010
Hide Arm/Group Description Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
MDX-010
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MDX-010
Affected / at Risk (%) # Events
Total   8/18 (44.44%)    
Blood and lymphatic system disorders   
Anemia  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Diarrhea-No Colostom  1  3/18 (16.67%)  3
General disorders   
Fatigue  1  1/18 (5.56%)  1
Investigations   
Blood gonadotrophin abnormal  1  1/18 (5.56%)  1
Lymphopenia  1  1/18 (5.56%)  1
Platelet count decreased  1  1/18 (5.56%)  1
Weight loss  1  2/18 (11.11%)  2
Metabolism and nutrition disorders   
Anorexia  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/18 (5.56%)  1
Nervous system disorders   
Facial nerve disorder  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MDX-010
Affected / at Risk (%) # Events
Total   16/18 (88.89%)    
Blood and lymphatic system disorders   
Anemia  1  4/18 (22.22%)  7
Cardiac disorders   
Atrial fibrillation  1  1/18 (5.56%)  1
Eye disorders   
Dry eye  1  1/18 (5.56%)  3
Gastrointestinal disorders   
Abdominal distension  1  1/18 (5.56%)  1
Constipation  1  2/18 (11.11%)  2
Diarrhea-No Colostom  1  9/18 (50.00%)  11
Dry mouth  1  1/18 (5.56%)  2
Lip pain  1  1/18 (5.56%)  2
Nausea  1  3/18 (16.67%)  4
Oral cavity Mucositis/stomatitis (functional/symptomatic)  1  1/18 (5.56%)  1
Pain-Abdominal  1  6/18 (33.33%)  9
Pain-Stomach  1  1/18 (5.56%)  1
Vomiting  1  2/18 (11.11%)  2
General disorders   
Edema: Limb  1  2/18 (11.11%)  2
Fatigue  1  12/18 (66.67%)  22
Fever-No ANC  1  2/18 (11.11%)  2
Rigors  1  1/18 (5.56%)  3
Investigations   
Alkaline phosphatase  1  1/18 (5.56%)  1
Aspartate aminotransferase increased  1  4/18 (22.22%)  5
Creatinine  1  1/18 (5.56%)  1
Leukopenia  1  4/18 (22.22%)  4
Lymphopenia  1  1/18 (5.56%)  1
Neutropenia  1  4/18 (22.22%)  5
Platelet count decreased  1  5/18 (27.78%)  9
Weight loss  1  1/18 (5.56%)  2
Metabolism and nutrition disorders   
Anorexia  1  4/18 (22.22%)  6
Glucose intolerance  1  1/18 (5.56%)  2
Hyperglycemia  1  2/18 (11.11%)  5
Hyperkalemia  1  2/18 (11.11%)  4
Hypermatremia  1  1/18 (5.56%)  1
Hypocalcemia  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/18 (5.56%)  2
Chest wall pain  1  1/18 (5.56%)  3
Myalgia  1  3/18 (16.67%)  3
Neck pain  1  1/18 (5.56%)  2
Pain in extremity  1  1/18 (5.56%)  1
Nervous system disorders   
Headache  1  4/18 (22.22%)  6
Reproductive system and breast disorders   
Impotence  1  1/18 (5.56%)  3
Pelvic pain  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/18 (5.56%)  2
Dyspnea  1  2/18 (11.11%)  5
Pharyngolaryngeal pain  1  1/18 (5.56%)  2
Pleural effusion  1  1/18 (5.56%)  2
Pulmonary  1  1/18 (5.56%)  1
Rhinitis Allergic  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Pain of skin  1  1/18 (5.56%)  1
Pruritus  1  2/18 (11.11%)  5
Rash/Desquamation  1  3/18 (16.67%)  6
Sweating  1  1/18 (5.56%)  1
Vascular disorders   
Hot flashes  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Stephen Ansell
Organization: Mayo Clinic
Phone: 507-284-0923
EMail: ansell.stephen@mayo.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00089076     History of Changes
Other Study ID Numbers: NCI-2012-02784
NCI-2012-02784 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC0312 ( Other Identifier: Mayo Clinic )
6359 ( Other Identifier: CTEP )
P30CA015083 ( U.S. NIH Grant/Contract )
U01CA069912 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2004
First Posted: August 5, 2004
Results First Submitted: May 11, 2012
Results First Posted: October 19, 2012
Last Update Posted: May 30, 2014