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Trial record 1 of 1 for:    SWOG S0806
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Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00972478
First received: September 4, 2009
Last updated: September 8, 2016
Last verified: September 2016
Results First Received: September 8, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stage II Contiguous Adult Diffuse Large Cell Lymphoma
Stage II Non-Contiguous Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Interventions: Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Prednisone
Biological: Rituximab
Drug: Vincristine Sulfate
Drug: Vorinostat

  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
Ph I: R-CHOP+Vorinostat (400mg D1-9) Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Ph I: R-CHOP+Vorinostat (400mg D1-9)   Ph II: R-CHOP+Vorinostat
STARTED   11   72 
Eligible and Began Protocol Therapy   9   63 
COMPLETED   4   34 
NOT COMPLETED   7   38 
Adverse Event                3                16 
Withdrawal by Subject                1                8 
Progression/Relapse                0                2 
Death                0                2 
Not protocol specified                1                1 
Ineligible                1                7 
Not start protocol treatment                1                2 



  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.
Eligible patients who began protocol therapy

Reporting Groups
  Description
Ph I: R-CHOP+Vorinostat (400mg D1-9) Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Ph I: R-CHOP+Vorinostat (400mg D1-9)   Ph II: R-CHOP+Vorinostat   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   63   72 
Age 
[Units: Years]
Median (Full Range)
 66.9 
 (46.4 to 83.8) 
 64.1 
 (19.6 to 80.8) 
 64.2 
 (19.6 to 83.8) 
Gender 
[Units: Participants]
     
Female   3   27   30 
Male   6   36   42 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   9   54   63 
Black   0   3   3 
Asian   0   5   5 
Unknown   0   1   1 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic   3   4   7 
Non-Hispanic   6   59   65 


  Outcome Measures
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1.  Primary:   Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)   [ Time Frame: 21 days ]

2.  Primary:   Progression-free Survival (Phase II)   [ Time Frame: Up to 2 years ]

3.  Secondary:   Overall Survival (Phase II)   [ Time Frame: Up to 2 years ]

4.  Secondary:   Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)   [ Time Frame: Up to week 26 ]

5.  Secondary:   Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL   [ Time Frame: Up to week 26 ]


  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:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG
phone: 206-667-4623



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00972478     History of Changes
Other Study ID Numbers: NCI-2011-01964
NCI-2011-01964 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000653803
S0806 ( Other Identifier: SWOG )
S0806 ( Other Identifier: CTEP )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: September 4, 2009
Results First Received: September 8, 2016
Last Updated: September 8, 2016
Health Authority: United States: Food and Drug Administration