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Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT01578967
Recruitment Status : Active, not recruiting
First Posted : April 17, 2012
Results First Posted : October 12, 2017
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hodgkin Lymphoma, Adult
Interventions: Drug: Brentuximab vedotin
Drug: ABVD

  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
ABVD Followed by Brentuximab Vedotin

Single arm trial

Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.

ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.

Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.

Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.


Participant Flow:   Overall Study
    ABVD Followed by Brentuximab Vedotin
STARTED   41 
COMPLETED   41 
NOT COMPLETED   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.
One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --> gray zone lymphoma).

Reporting Groups
  Description
ABVD Followed by Brentuximab Vedotin

Single arm trial

Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.

ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.

Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.

Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.


Baseline Measures
   ABVD Followed by Brentuximab Vedotin 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 29 
 (19 to 67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  57.5% 
Male      17  42.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   2.5% 
Not Hispanic or Latino      39  97.5% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   7.5% 
White      36  90.0% 
More than one race      0   0.0% 
Unknown or Not Reported      1   2.5% 
Region of Enrollment 
[Units: Participants]
 
United States   40 
Stage [1] 
[Units: Participants]
Count of Participants
 
    2   5.0% 
IIA      28  70.0% 
IIB      10  25.0% 
[1] The stage of lymphoma describes the extent of the spread of the tumor, using the terms stage I through IV (1 through 4). Each stage may also be further divided into “A” and “B” categories, based on whether or not the patient is experiencing specific symptoms. Where larger numbers indicate a worse outcome.
Risk [1] 
[Units: Participants]
Count of Participants
 
Favorable      18  45.0% 
UnFavorable      22  55.0% 
[1] patients with early stage HL can be stratified into two risk groups: Favorable and unfavorable. This is based on the presence or absence of certain clinical features, such as age, B symptoms, erythrocyte sedimentation rate (ESR), large number of regions involved, and large mediastinal adenopathy.


  Outcome Measures

1.  Primary:   Percentage of Patients With Positron Emission Tomography (PET) Negative Disease   [ Time Frame: 12 months ]

2.  Secondary:   Number of Participant Who Achieved a Complete Response   [ Time Frame: 12 months ]

3.  Secondary:   Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response.   [ Time Frame: 12 months ]

4.  Secondary:   Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher   [ Time Frame: 12 months ]

5.  Secondary:   Progression Free Survival   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Time to Progression   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Exploratory Objective Whether the Cytokine Profile Changes After Treatment   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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 less than or equal to 60 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: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125
e-mail: Robin_V_Johnson@med.unc.edu



Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01578967     History of Changes
Other Study ID Numbers: LCCC 1115
First Submitted: April 13, 2012
First Posted: April 17, 2012
Results First Submitted: September 11, 2017
Results First Posted: October 12, 2017
Last Update Posted: April 25, 2018