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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
February 9, 2012
February 16, 2012
June 7, 2017
August 30, 2017
August 30, 2017
March 2012
January 2015   (Final data collection date for primary outcome measure)
Complete Response Rate [ Time Frame: End of Therapy (median duration of four months) ]
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.
Investigate clinical activity of Brentuximab w/AVD in cHL [ Time Frame: 2 years ]
Primary clinical endpoint is complete remission rate measured by PET/CT. Overall response rate, Failure-free survival and overall survival will also be assessed.
Complete list of historical versions of study NCT01534078 on ClinicalTrials.gov Archive Site
  • Overall Response Rate After One Cycle of Brentuximab [ Time Frame: 28 days ]

    The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.

    • CR: Disappearance of all evidence of disease
    • PR: Regression of measurable disease and no new sites
  • Overall Response Rate [ Time Frame: End of Therapy (median duration of four months) ]

    The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.

    • CR: Disappearance of all evidence of disease
    • PR: Regression of measurable disease and no new sites
  • Grade III or IV Adverse Events [ Time Frame: 2 years ]
    A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.
  • Estimate clinical activity of Brentuximab after one cycle [ Time Frame: 2 years ]
    Measured via PET/CT response
  • Safety and Tolerability of Brentuximab [ Time Frame: 2 years ]
    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 ]
    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
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Active, not recruiting
34
December 2018
January 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01534078
11-462
Yes
Not Provided
Not Provided
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
August 2017

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