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Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01534078
First Posted: February 16, 2012
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
H. Lee Moffitt Cancer Center and Research Institute
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
Results First Submitted: June 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hodgkin Lymphoma
Interventions: Drug: Brentuximab Vedotin
Drug: Adriamycin, vinblastine, and dacarbazine

  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
Treatment Arm

Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine (AVD)

Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg

Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine


Participant Flow:   Overall Study
    Treatment Arm
STARTED   34 
COMPLETED   32 
NOT COMPLETED   2 
Death                1 
Withdrawal by Subject                1 



  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.
No text entered.

Reporting Groups
  Description
Treatment Arm

Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine

Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg

Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine


Baseline Measures
   Treatment Arm 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 34 
   36 
 (20 to 75) 
Age, Customized 
[Units: Participants]
Count of Participants
 
20 - 30 years   
Participants Analyzed 
[Units: Participants]
 34 
20 - 30 years   10 
31 - 40 years   
Participants Analyzed 
[Units: Participants]
 34 
31 - 40 years   9 
41 - 60 years   
Participants Analyzed 
[Units: Participants]
 34 
41 - 60 years   10 
61 - 75 years   
Participants Analyzed 
[Units: Participants]
 34 
61 - 75 years   5 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 34 
Female      17  50.0% 
Male      17  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 34 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      26  76.5% 
Unknown or Not Reported      8  23.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
More Than One Race   
Participants Analyzed 
[Units: Participants]
 34 
More Than One Race   1 
Other   
Participants Analyzed 
[Units: Participants]
 34 
Other   7 
White   
Participants Analyzed 
[Units: Participants]
 34 
White   26 
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed 
[Units: Participants]
 34 
United States   34 
Stage [1] 
[Units: Participants]
Count of Participants
 
IA   
Participants Analyzed 
[Units: Participants]
 34 
IA   6 
IIA   
Participants Analyzed 
[Units: Participants]
 34 
IIA   24 
IIB   
Participants Analyzed 
[Units: Participants]
 34 
IIB   4 
[1]

Lugano Classification of disease stage

  • Stage I: Found in only 1 lymph node or lymphoid organ or the cancer is found in only 1 area of a single organ outside the lymph system.
  • Stage II: The cancer is found in 2 or more lymph node areas on the same side of the diaphragm or the cancer extends locally from one lymph node area into a nearby organ

Can be assigned a letter A or B. B is when a patient has any of the following symptoms:

  • Loss of > than 10% of body weight over the previous 6 months without dieting
  • Unexplained fever of at least 100.4°F (38°C)
  • Drenching night sweats
Cellularity [1] 
[Units: Participants]
Count of Participants
 
Hypercellular   
Participants Analyzed 
[Units: Participants]
 34 
Hypercellular   1 
Hypocellular   
Participants Analyzed 
[Units: Participants]
 34 
Hypocellular   4 
Normocellular   
Participants Analyzed 
[Units: Participants]
 34 
Normocellular   10 
Missing   
Participants Analyzed 
[Units: Participants]
 34 
Missing   19 
[1] Hypercellular indicates more cells are being produce than expected, hypocellular means that fewer than expect number of cells are being produced, normocellular means an approximately normal amount of cells are being produced
Histology [1] 
[Units: Participants]
Count of Participants
 
Classical Hodgkin Lymphoma, NOS   
Participants Analyzed 
[Units: Participants]
 34 
Classical Hodgkin Lymphoma, NOS   8 
Lymphocytic Rich   
Participants Analyzed 
[Units: Participants]
 34 
Lymphocytic Rich   4 
Mixed Cellularity   
Participants Analyzed 
[Units: Participants]
 34 
Mixed Cellularity   4 
Nodular Sclerosis   
Participants Analyzed 
[Units: Participants]
 34 
Nodular Sclerosis   18 
[1]

The histological subtypes of classic Hodgkin lymphoma:

  • Classical NOS: Not Otherwise Specified (specific subtype not identified)
  • Lymphocyte-Rich: Rarely found in more than a few lymph nodes and usually occurs in the upper half of the body
  • Mixed Cellularity: Seen predominantly in adults, this is the second most common type. It can start in any lymph node but most often occurs in the upper half of the body.
  • Nodular Sclerosis: The most common type in developed countries. This most common in teens and young adults. Tends to start in lymph nodes in the chest or neck.
Risk Class [1] 
[Units: Participants]
Count of Participants
 
Early Favorable   
Participants Analyzed 
[Units: Participants]
 34 
Early Favorable   21 
Early Unfavorable   
Participants Analyzed 
[Units: Participants]
 34 
Early Unfavorable   13 
[1]

Early Unfavorable: Stage I or II disease and one or more of the following risk factors:

  • B Symptoms (see stage description)
  • Extranodal disease
  • Bulky disease (≥10 cm or >33% of the chest diameter on chest x-ray)
  • Three or more sites of nodal involvement
  • Sedimentation rate of ≥50 mm/h

Early Favorable: Stage I or II disease with none of the risk factors listed above. Patients with favorable classification tend to have better outcomes.

Number of Lesions [1] 
[Units: Lesions]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 33 
   5 
 (1 to 6) 
[1] Information is missing for one participant
Longest Tumor Diameter [1] 
[Units: Centimeters (cm)]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 33 
   33.4 
 (15.1 to 83.3) 
[1] Information is missing for one participant


  Outcome Measures
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1.  Primary:   Complete Response Rate   [ Time Frame: End of Therapy (median duration of four months) ]

2.  Secondary:   Overall Response Rate After One Cycle of Brentuximab   [ Time Frame: 28 days ]

3.  Secondary:   Overall Response Rate   [ Time Frame: End of Therapy (median duration of four months) ]

4.  Secondary:   Grade III or IV Adverse Events   [ Time Frame: 2 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeremy Abramson, MD
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: JABRAMSON@mgh.harvard.edu



Responsible Party: Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01534078     History of Changes
Other Study ID Numbers: 11-462
First Submitted: February 9, 2012
First Posted: February 16, 2012
Results First Submitted: June 7, 2017
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017