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S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00822120
Recruitment Status : Active, not recruiting
First Posted : January 14, 2009
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma
Nonneoplastic Condition
Interventions: Biological: bleomycin sulfate
Biological: filgrastim
Drug: ABVD regimen
Drug: BEACOPP regimen
Drug: cyclophosphamide
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate

  Participant Flow

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
HIV-negative: Initial ABVD Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
HIV-positive: Initial ABVD Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
HIV-negative and PET-negative: Continued ABVD Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
HIV-negative and PET-positive: BEACOPP Escalated Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
HIV-positive and PET-negative: Continued ABVD Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
HIV-positive and PET-positive: BEACOPP Standard Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles

Participant Flow for 2 periods

Period 1:   Initial Registration
    HIV-negative: Initial ABVD   HIV-positive: Initial ABVD   HIV-negative and PET-negative: Continued ABVD   HIV-negative and PET-positive: BEACOPP Escalated   HIV-positive and PET-negative: Continued ABVD   HIV-positive and PET-positive: BEACOPP Standard
STARTED   358   13   0   0   0   0 
Eligible and Evaluable Patients   336   12   0   0   0   0 
COMPLETED   332   12   0   0   0   0 
NOT COMPLETED   26   1   0   0   0   0 
Adverse Event                1                0                0                0                0                0 
Refusal Unrelated to Adverse Event                1                0                0                0                0                0 
Reasons not Protocol Specified                2                0                0                0                0                0 
Ineligible                22                1                0                0                0                0 

Period 2:   PET-directed Therapy
    HIV-negative: Initial ABVD   HIV-positive: Initial ABVD   HIV-negative and PET-negative: Continued ABVD   HIV-negative and PET-positive: BEACOPP Escalated   HIV-positive and PET-negative: Continued ABVD   HIV-positive and PET-positive: BEACOPP Standard
STARTED   0   0   270   55   10   1 
Eligibile and Evaluable Patients   0   0   270   55   10   1 
COMPLETED   0   0   270   45   10   1 
NOT COMPLETED   0   0   0   10   0   0 
Adverse Event                0                0                0                1                0                0 
Refusal Unrelated to Adverse Event                0                0                0                1                0                0 
Death                0                0                0                2                0                0 
Protocol Violation                0                0                0                6                0                0 



  Baseline Characteristics

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.
Only eligible and evaluable HIV-positive patients were included in the analysis.

Reporting Groups
  Description
HIV-negative: Initial ABVD Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
HIV-positive: Initial ABVD Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
Total Total of all reporting groups

Baseline Measures
   HIV-negative: Initial ABVD   HIV-positive: Initial ABVD   Total 
Overall Participants Analyzed 
[Units: Participants]
 336   12   348 
Age 
[Units: Years]
Median (Full Range)
 32.1 
 (18 to 60) 
 44.6 
 (25 to 50) 
 32.4 
 (18 to 60) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      147  43.8%      2  16.7%      149  42.8% 
Male      189  56.3%      10  83.3%      199  57.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      28   8.3%      3  25.0%      31   8.9% 
Not Hispanic or Latino      273  81.3%      8  66.7%      281  80.7% 
Unknown or Not Reported      35  10.4%      1   8.3%      36  10.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      7   2.1%      0   0.0%      7   2.0% 
Native Hawaiian or Other Pacific Islander      3   0.9%      0   0.0%      3   0.9% 
Black or African American      32   9.5%      4  33.3%      36  10.3% 
White      274  81.5%      5  41.7%      279  80.2% 
More than one race      3   0.9%      0   0.0%      3   0.9% 
Unknown or Not Reported      17   5.1%      3  25.0%      20   5.7% 


  Outcome Measures

1.  Primary:   Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.   [ Time Frame: 2 years ]

2.  Primary:   Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS   [ Time Frame: 2 years ]

3.  Secondary:   Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging   [ Time Frame: 2 years ]

4.  Secondary:   Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD   [ Time Frame: 7 months after registration ]

5.  Secondary:   Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 1 year ]

6.  Secondary:   Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.   [ Time Frame: 2 years ]

7.  Secondary:   Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.   [ Time Frame: 5 years ]

8.  Secondary:   Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD   [ Time Frame: 7 months after registration ]

9.  Secondary:   Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Lymphoma Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00822120     History of Changes
Other Study ID Numbers: CDR0000630501
S0816 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: January 13, 2009
First Posted: January 14, 2009
Results First Submitted: October 3, 2017
Results First Posted: April 4, 2018
Last Update Posted: April 4, 2018