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A Safety Study of Growth Factor Use in Treatment With Brentuximab Vedotin Plus Chemotherapy

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ClinicalTrials.gov Identifier: NCT03646123
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This trial will study a treatment combination for Hodgkin lymphoma. The drugs used in this trial are a targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are referred to as "A+AVD." Patients will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment (12 doses). The trial will look at whether the drug combination reduces the number of patients who experience the side effect of febrile neutropenia. Febrile neutropenia is a very low white blood cell count and a fever, which can be life threatening.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: brentuximab vedotin Drug: doxorubicin Drug: vinblastine Drug: dacarbazine Drug: G-CSF Phase 4

Detailed Description:
This study will evaluate the impact of granulocyte colony stimulating factor primary prophylaxis (G-PP) administration during treatment with A+AVD on the incidence of febrile neutropenia, efficacy, and dose intensity in patients with advanced stage Hodgkin lymphoma. Patients will be treated using institutional standard of care practices for the majority of treatment decisions. A+AVD will be administered on days 1 and 15 of a 28-day cycle, with the addition of G-PP 24-36 hours postdose. Patients will receive 6 cycles of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated With A+AVD
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A+AVD
Arm Description: Brentuximab vedotin (A) plus doxorubicin (+A), vinblastine (V), and dacarbazine (D) administered by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
Drug: brentuximab vedotin
1.2 mg/kg by IV infusion
Other Names:
  • Adcetris
  • SGN-35

Drug: doxorubicin
25 mg/m^2 by IV infusion

Drug: vinblastine
6 mg/m^2 by IV infusion

Drug: dacarbazine
375 mg/m^2 by IV infusion

Drug: G-CSF
Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD
Other Names:
  • filgrastim
  • pegfilgrastim




Primary Outcome Measures :
  1. Febrile Neutropenia (FN) Rate [ Time Frame: Up to 6 months ]
    Proportion of patients with treatment-emergent incidence of FN


Secondary Outcome Measures :
  1. Primary Refractory Disease Rate [ Time Frame: Up to 9 months ]
    Proportion of patients with less than complete response (CR) or relapse within 3 months of end of treatment (EOT)

  2. CR Rate [ Time Frame: Up to 6 months ]
    Proportion of patients with CR at EOT

  3. Physician-reported Progression Free Survival (PFS) [ Time Frame: Up to 2.5 years ]
    The physician-reporting PFS is defined as the time from start of study treatment to first documentation of progression per investigator or to death due to any cause, whichever comes first.

  4. Subsequent Anticancer Therapy Utilization Rate [ Time Frame: Up to 2.5 years ]
    Proportion of patients with subsequent anticancer therapies

  5. Mean Dose Intensity [ Time Frame: Up to 6 months ]
  6. Rate of Dose Reduction and Delays [ Time Frame: Up to 6 months ]
    Proportion of patients with dose reductions or delays related to any component of A+AVD



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment-naïve, Hodgkin lymphoma (HL) patients with Ann Arbor Stage 3 or 4 disease
  • Histologically confirmed classical HL according to the current World Health Organization (WHO) Classification
  • Bidimensional measureable disease as documented by radiographic technique

Exclusion Criteria:

  • Nodular lymphocyte predominant HL
  • History of another malignancy within 2 years of the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Patients with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of the first study drug dose
  • Active cerebral/meningeal disease related to the underlying malignancy
  • Any active Grade 3 or higher viral, bacterial, or fungal infection within two weeks of the first dose of study drug (Grade 3 defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03)
  • Current therapy with other systemic anti-neoplastic or investigational agents
  • Grade 3 or higher pulmonary disease unrelated to underlying malignancy
  • History of a cerebral vascular event within 6 months of first dose of study drug
  • Child-Pugh B or C hepatic impairment
  • Any peripheral sensory or motor neuropathy
  • Patients who are pregnant or breastfeeding
  • Other serious condition that would impair the patient's ability to receive or tolerate the planned treatment and follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646123


Contacts
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, California
Compassionate Care Research Group Recruiting
Fountain Valley, California, United States, 92708
Contact: Haresh Jhangiani    714-698-0300    hjhangiani1@gmail.com   
Principal Investigator: Haresh Jhangiani         
United States, Florida
Florida Cancer Specialists - North Region Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Joseph Mace    727-216-1143    jmace@flcancer.com   
Principal Investigator: Joseph Mace         
United States, New Jersey
New Jersey Hematology Oncology Associates, LLC Recruiting
Brick, New Jersey, United States, 08724
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
Regional Cancer Care Associates - Freehold Recruiting
Freehold, New Jersey, United States, 07728
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
Regional Cancer Care Associates - Howell Recruiting
Howell, New Jersey, United States, 07731
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
Regional Cancer Care Associates - Mount Holly Recruiting
Mount Holly, New Jersey, United States, 08060
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
Regional Cancer Care Associates - Central Jersey Recruiting
Somerville, New Jersey, United States, 08876
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
Regional Cancer Care Associates - Sparta Recruiting
Sparta, New Jersey, United States, 07871
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
United States, New York
Clinical Research Alliance - Morton Coleman, MD Recruiting
Lake Success, New York, United States, 11042
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
CareMount Medical Group Recruiting
Mount Kisco, New York, United States, 10549-3412
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
Clinical Research Alliance - Abraham Mittelman, MD, LLC Recruiting
Purchase, New York, United States, 10577
Contact: Colleen Kats    516-488-2918    ckats@researchcra.com   
Principal Investigator: Morton Coleman         
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Judah Friedman    440-286-5050    judah.friedman@uhhospitals.org   
Principal Investigator: Judah Friedman         
United States, Tennessee
Tennessee Oncology - Nashville Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ian Flinn    615-329-7274    iflinn@tnonc.com   
Principal Investigator: Ian Flinn         
United States, Texas
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Matthew Peterson    210-916-6576    matthew.r.peterson20.mil@mail.mil   
Principal Investigator: Matthew Peterson         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Linda Ho, MD Seattle Genetics, Inc.

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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03646123     History of Changes
Other Study ID Numbers: SGN35-027
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 26, 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seattle Genetics, Inc.:
Brentuximab vedotin
Doxorubicin
Vinblastine
Dacarbazine

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