Trial Outcomes & Findings for Oblimersen Sodium & Combination Chemotherapy in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (NCT NCT00736450)

NCT ID: NCT00736450

Last Updated: 2023-10-24

Results Overview

The time from tissue harvest to release of microarray test and IHC assay results will be noted in days.

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 37 participants
• Primary outcome timeframe: Upto 14 days
• Results posted on: 2023-10-24

Participant Flow

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.

Participant milestones

Measure	Arm I 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 Study STARTED	37
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Arm I 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 Study Not ABC gene eligible	19
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	1

Baseline Characteristics

The mean age was calculated from only the 14 subjects that received study treatment.

Baseline characteristics by cohort

Measure	Arm I n=37 Participants 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
Age, Continuous	53 years n=14 Participants • The mean age was calculated from only the 14 subjects that received study treatment.
Sex: Female, Male Female	15 Participants n=37 Participants
Sex: Female, Male Male	22 Participants n=37 Participants
Region of Enrollment United States	37 participants n=37 Participants

PRIMARY outcome

Timeframe: Upto 14 days

The time from tissue harvest to release of microarray test and IHC assay results will be noted in days.

Outcome measures

Measure

Arm I n=13 Participants 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

Time to Perform Microarray Study After Receipt of Tissue

4.4 days Interval 0.0 to 14.0

PRIMARY outcome

Timeframe: Upto 7 days

Outcome measures

Measure	Arm I n=13 Participants 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
Number of Participants With Microarray Testing Results Are Completed Within 7 Days. results in more than 7 days	2 Participants
Number of Participants With Microarray Testing Results Are Completed Within 7 Days. results within 7 days or less	11 Participants

SECONDARY outcome

Timeframe: End of treatment, an average of 4 months

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

Outcome measures

Measure	Arm I n=13 Participants 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
Efficacy of Treatment, in Terms of Complete Response Rate (Anyone Achieving a CR or Cru) complete response	12 Participants
Efficacy of Treatment, in Terms of Complete Response Rate (Anyone Achieving a CR or Cru) partial response	1 Participants

Adverse Events

Arm I

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=14 participants at risk 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
Blood and lymphatic system disorders Febrile Neutropenia	7.1% 1/14 • Number of events 2 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Investigations Platelet count decreased	7.1% 1/14 • Number of events 3 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Metabolism and nutrition disorders Hyponatremia	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Psychiatric disorders confusion	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Investigations Neutrophil count decreased	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Investigations White blood cells decreased	7.1% 1/14 • Number of events 2 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Infections and infestations Urinary tract infection	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Gastrointestinal disorders Rectal hemorrhage	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.

Other adverse events

Measure	Arm I n=14 participants at risk 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
Investigations White blood cell decreased	71.4% 10/14 • Number of events 22 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Investigations Neutrophil count decreased	71.4% 10/14 • Number of events 36 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Injury, poisoning and procedural complications Vascular access complication	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
General disorders Infusion related reaction	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Infections and infestations Infections and infestations - Other	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Vascular disorders Thromboembolic event	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Blood and lymphatic system disorders anemia	14.3% 2/14 • Number of events 2 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Metabolism and nutrition disorders hypokalemia	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Infections and infestations Platelet count decreased	28.6% 4/14 • Number of events 6 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Infections and infestations Sinusitis	7.1% 1/14 • Number of events 1 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Metabolism and nutrition disorders Hyponatremia	14.3% 2/14 • Number of events 3 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Investigations lymphocyte count decreased	7.1% 1/14 • Number of events 5 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Infections and infestations sepsis	7.1% 1/14 • Number of events 2 • Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months) Only reporting all Serious adverse events and Other AEs grade 3 and 4.

Additional Information

Julie Vose

University of Nebraska Medical Center

Phone: 402-559-3848

Email: jmvose@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place