NCT01578967

Brief Summary

The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive radiation therapy. The use of chemotherapy and radiation may cause long term treatment related side effects such as heart problems and other cancers. Researchers are trying to find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy cycles given is just as effective as the standard Hodgkin treatment. Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational. Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some cancer cells and some normal cells of the immune system. The purpose of this research study is to see the effects of treatment with fewer cycles of the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on study participants and Hodgkins lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 12, 2017

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

December 7, 2021

Status Verified

November 1, 2021

Enrollment Period

4.4 years

First QC Date

April 13, 2012

Results QC Date

September 11, 2017

Last Update Submit

November 8, 2021

Conditions

Hodgkin Lymphoma, Adult

Keywords

Hodgkin's lymphomaHodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Positron Emission Tomography (PET) Negative Disease

    Percentage of patients who convert to PET negative disease post consolidation. This is defined by PET with Deauville \<=2. The Deauville 5-point scoring system is a five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG Positron emission tomography: Score 1: No uptake above the background Score 2: Uptake ≤ mediastinum Score 3: Uptake \> mediastinum but ≤ liver Score 4: Uptake moderately increased compared to the liver at any site Score 5: Uptake markedly increased compared to the liver at any site Score X: New areas of uptake unlikely to be related to lymphoma

    12 months

Secondary Outcomes (5)

  • Number of Participant Who Achieved a Complete Response

    12 months

  • Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response.

    12 months

  • 3 Year Progression Free Survival Rate

    3 years

  • 3 Year Time to Progression Rate

    3 years

  • Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher

    12 months

Study Arms (1)

ABVD followed by Brentuximab vedotin

OTHER

Single arm trial

Drug: Brentuximab vedotinDrug: ABVD

Interventions

Brentuximab vedotinDRUG

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

Also known as: SGN-35, Adcetris
ABVD followed by Brentuximab vedotin
ABVDDRUG

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.

ABVD followed by Brentuximab vedotin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Previously untreated stage I or II non-bulky Hodgkin lymphoma
  • No mediastinal mass \>0.33 maximum intrathoracic diameter on chest x-ray (see Appendix B)
  • No adenopathy ≥7.5 cm in its largest diameter
  • Measurable disease as assessed by 2 dimensional measurement by CT (\>2cm or 1.5 cm if 0.5 cm slices are used, as in spiral CT scan)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Age ≥18 years and ≤60 years of age
  • Life expectancy of at least 3 months
  • Adequate bone marrow function (without transfusion support within one week of screening) as demonstrated by:
  • Hemoglobin ≥ 8 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
  • Platelet count ≥ 75,000/mm3
  • Adequate hepatic and renal function as demonstrated by:
  • Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
  • Total serum bilirubin ≤1.5 x ULN
  • Serum creatinine ≤ 2.0 mg/dL
  • +12 more criteria

You may not qualify if:

  • Prior therapies for treatment of HL including involved field radiation therapy or any prior treatment for any malignancy with anthracyclines.
  • Bulky disease (defined as a mass measuring \> 7.5 cm or one-third the maximal diameter of the thoracic cavity)
  • Known central nervous system (CNS) involvement
  • Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
  • Known history of human immunodeficiency virus (HIV), hepatitis B and hepatitis C (testing is not necessary if patient does not have history of these diseases, and no risk factors for acquisition of these viruses)
  • Cardiac disease with left ventricular ejection fraction of less than 45%
  • Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD
  • Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective
  • Other active malignancies with the exception of:
  • Non-melanoma skin cancer
  • Cervical carcinoma in situ without evidence of disease
  • Prostatic intraepithelial neoplasia without evidence of prostate cancer
  • Pregnant or lactating women
  • Prior to Day 1 of brentuximab vedotin, please verify the patient does not meet the criteria below:
  • Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Levine Cancer Istitute, Carolinas Health Care system

Charlotte, North Carolina, 28204, United States

Location

Rex Cancer Center

Raleigh, North Carolina, 27607, United States

Location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

Related Publications (1)

  • Park SI, Shea TC, Olajide O, Reddy NM, Budde LE, Ghosh N, Deal AM, Noe JF, Ansell SM. ABVD followed by BV consolidation in risk-stratified patients with limited-stage Hodgkin lymphoma. Blood Adv. 2020 Jun 9;4(11):2548-2555. doi: 10.1182/bloodadvances.2020001871.

    PMID: 32516414DERIVED

Related Links

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Robin V. Johnson
Organization
UNC Lineberger Comprehensive Cancer Center
Robin_V_Johnson@med.unc.edu
919-966-1125

Study Officials

  • Thomas Shea, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 17, 2012

Study Start

April 1, 2012

Primary Completion

August 10, 2016

Study Completion

December 11, 2020

Last Updated

December 7, 2021

Results First Posted

October 12, 2017

Record last verified: 2021-11

Locations

US(6)