Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01534078
First received: February 9, 2012
Last updated: March 24, 2014
Last verified: March 2014

February 9, 2012
March 24, 2014
March 2012
April 2015   (final data collection date for primary outcome measure)
Investigate clinical activity of Brentuximab w/AVD in cHL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Primary clinical endpoint is complete remission rate measured by PET/CT. Overall response rate, Failure-free survival and overall survival will also be assessed.
Same as current
Complete list of historical versions of study NCT01534078 on ClinicalTrials.gov Archive Site
  • Estimate clinical activity of Brentuximab after one cycle [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured via PET/CT response
  • Safety and Tolerability of Brentuximab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Measured by rate of adverse events and discontinuation of therapy due to toxicity.
  • Correlation of serum soluble CD30 and/or TARC and clinical response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To investigate whether elevated baseline serum soluble CD30 and/or the chemokine ligand 17/thymus activation-related chemokine (TARC) correlate with clinical response, PET-CT results or rate of relapse
Same as current
Not Provided
Not Provided
 
Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma

Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.

The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.

In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.

Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).

The following test and procedures will be performed on Days 1 and 15 of each cycle:

  • Review of any side effects you have experienced and all medications you are taking
  • Performance Status
  • Physical exam and vital signs
  • Routine blood tests
  • Questionnaire to evaluate symptoms of neuropathy
  • Research blood sample to look at markers to see how your body is responding to study medication
  • PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD

After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:

  • Review of any side effects you have experienced and all medications you are taking
  • Performance Status
  • Physical exam and vital signs
  • Routine blood tests
  • Questionnaire to evaluate symptoms of neuropathy
  • Research blood sample to look at markers to see how your body is responding to study medication
  • PET-CT scan Follow up will include the following
  • Review of any side effects you have experienced and all medications you are taking
  • Performance Status
  • Review and Physical exam
  • Routine blood tests
  • Questionnaire to evaluate symptoms of neuropathy
  • CT scans
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Lymphoma
  • Drug: Brentuximab Vedotin
    2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
    Other Names:
    • Adcetris
    • SGN-35
    • SGN35
  • Drug: Adriamycin, vinblastine, and dacarbazine
    Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
    Other Names:
    • Doxorubicin
    • Velban
    • DTIC
Experimental: Treatment Arm
Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Interventions:
  • Drug: Brentuximab Vedotin
  • Drug: Adriamycin, vinblastine, and dacarbazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
Not Provided
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
  • Non-bulky disease defined as less than 10 cm in maximal diameter
  • Measurable disease greater than or equal to 1.5 cm
  • ECOG performance status of 0 or 2
  • Willing to use 2 effective forms of birth control

Exclusion Criteria:

  • No prior chemotherapy or radiotherapy for Hodgkin lymphoma
  • Not receiving any other investigational agents
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
  • No pre-existing grade 3 or greater neuropathy
  • No uncontrolled intercurrent illness
  • Not pregnant or breastfeeding
  • No history of a different malignancy unless disease free for at least one year
Both
18 Years and older
No
Contact: Jeremy S Abramson, M.D. 617-724-4000 jabramson@partners.org
United States
 
NCT01534078
11-462
Yes
Jeremy Abramson, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • H. Lee Moffitt Cancer Center and Research Institute
  • Seattle Genetics, Inc.
Principal Investigator: Jeremy Abramson, M.D. Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP