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Oblimersen Sodium and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I, Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00736450
Recruitment Status : Terminated (Manufacturer is no longer making the drug.)
First Posted : August 15, 2008
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genta Incorporated
Information provided by (Responsible Party):
Julie M Vose, MD, University of Nebraska

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Interventions Biological: oblimersen sodium
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Procedure: biopsy
Genetic: microarray analysis
Other: immunohistochemistry staining method
Genetic: gene expression analysis
Genetic: cytogenetic analysis
Enrollment 37
Recruitment Details  
Pre-assignment Details

Of the 37 subjects consented, 19 were Not ABC gene type positive so were removed from the study.

Of the 18 remaining eligible, 4 patients opted for standard of care and withdrew from the study.

13 subjects had microarray analysis conducted with tissue.

Arm/Group Title Arm I
Hide Arm/Group Description

Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).

oblimersen sodium: Given IV

rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV

prednisone: Given orally

Period Title: Overall Study
Started 37
Completed 12
Not Completed 25
Reason Not Completed
Not ABC gene eligible             19
Withdrawal by Subject             5
Physician Decision             1
Arm/Group Title Arm I
Hide Arm/Group Description

Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).

oblimersen sodium: Given IV

rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV

prednisone: Given orally

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
53
(30 to 75)
[1]
Measure Analysis Population Description: The mean age was calculated from only the 14 subjects that received study treatment.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
15
  40.5%
Male
22
  59.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Time to Perform Microarray Study After Receipt of Tissue
Hide Description The time from tissue harvest to release of microarray test and IHC assay results will be noted in days.
Time Frame Upto 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).

oblimersen sodium: Given IV

rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV

prednisone: Given orally

Overall Number of Participants Analyzed 13
Mean (Full Range)
Unit of Measure: days
4.4
(0 to 14)
2.Primary Outcome
Title Number of Participants With Microarray Testing Results Are Completed Within 7 Days.
Hide Description [Not Specified]
Time Frame Upto 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).

oblimersen sodium: Given IV

rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV

prednisone: Given orally

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
results within 7 days or less 11
results in more than 7 days 2
3.Secondary Outcome
Title Efficacy of Treatment, in Terms of Complete Response Rate (Anyone Achieving a CR or Cru)
Hide Description Response criteria are the recommendations of the International Harmonization Project’s update to the International Working Group guidelines. Complete response (CR) is defined as disappearance of all evidence of disease; Partial response (PR) is defined as regression of measurable disease and no new sites
Time Frame End of treatment, an average of 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).

oblimersen sodium: Given IV

rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV

prednisone: Given orally

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
complete response
12
  92.3%
partial response
1
   7.7%
Time Frame Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months)
Adverse Event Reporting Description Only reporting all Serious adverse events and Other AEs grade 3 and 4.
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide).

oblimersen sodium: Given IV

rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV

prednisone: Given orally

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   2/14 (14.29%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  1  1/14 (7.14%)  2
Gastrointestinal disorders   
Abdominal pain  1  1/14 (7.14%)  1
Rectal hemorrhage  1  1/14 (7.14%)  1
Infections and infestations   
Urinary tract infection  1  1/14 (7.14%)  1
Investigations   
Platelet count decreased  1 [1]  1/14 (7.14%)  3
Neutrophil count decreased  1  1/14 (7.14%)  1
White blood cells decreased  1 [2]  1/14 (7.14%)  2
Metabolism and nutrition disorders   
Hyponatremia  1  1/14 (7.14%)  1
Psychiatric disorders   
confusion  1  1/14 (7.14%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
thrombocytopenia
[2]
Leukocyte count decreased
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%) # Events
Total   12/14 (85.71%)    
Blood and lymphatic system disorders   
anemia  1 [1]  2/14 (14.29%)  2
Gastrointestinal disorders   
Constipation  1  1/14 (7.14%)  1
General disorders   
Infusion related reaction  1 [2]  1/14 (7.14%)  1
Infections and infestations   
Infections and infestations - Other  1 [3]  1/14 (7.14%)  1
Platelet count decreased  1  4/14 (28.57%)  6
Infections and infestations - Other  1 [4]  1/14 (7.14%)  1
Sinusitis  1 [5]  1/14 (7.14%)  1
sepsis  1  1/14 (7.14%)  2
Injury, poisoning and procedural complications   
Vascular access complication  1 [6]  1/14 (7.14%)  1
Injury, poisoning and procedural complications - Other  1 [7]  1/14 (7.14%)  1
Investigations   
White blood cell decreased  1 [8]  10/14 (71.43%)  22
Neutrophil count decreased  1  10/14 (71.43%)  36
lymphocyte count decreased  1  1/14 (7.14%)  5
Metabolism and nutrition disorders   
hypokalemia  1  1/14 (7.14%)  1
Hyponatremia  1  2/14 (14.29%)  3
Nervous system disorders   
Headache  1  1/14 (7.14%)  1
Vascular disorders   
Thromboembolic event  1 [9]  1/14 (7.14%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
low hemoglobin
[2]
reaction to rituxan
[3]
oral infection
[4]
opportunistic infection
[5]
maxillary
[6]
Thrombus- right arm related to PIC line.
[7]
infection, port site
[8]
leukocytes
[9]
deep vein thrombosis
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie Vose, MD
Organization: University of Nebraska Medical Center
Phone: 402-559-3848
EMail: jmvose@unmc.edu
Layout table for additonal information
Responsible Party: Julie M Vose, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT00736450     History of Changes
Other Study ID Numbers: 462-07
NCI-2009-01692 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA036727 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: January 30, 2018
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018