Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
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: October 23, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Hodgkin Lymphoma
Drug: Brentuximab Vedotin
Drug: Adriamycin, vinblastine, and dacarbazine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 34
Study Start Date: March 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
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

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534078

Locations
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hosptial
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
H. Lee Moffitt Cancer Center and Research Institute
Seattle Genetics, Inc.
Investigators
Principal Investigator: Jeremy Abramson, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jeremy Abramson, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01534078     History of Changes
Other Study ID Numbers: 11-462
Study First Received: February 9, 2012
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
non-bulky
limited stage

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Doxorubicin
Liposomal doxorubicin
Vinblastine
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014