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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 28, 2019
End Date:March 2023
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated With A+AVD

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.

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.

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
We found this trial at
14
sites
Sparta, New Jersey 07871
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Principal Investigator: Matthew Peterson
Phone: 210-916-6576
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Fort Sam Houston, TX
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Brick, New Jersey 08724
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Brick, NJ
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Cleveland, Ohio 44106
Principal Investigator: Judah Friedman
Phone: 440-286-5050
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Cleveland, OH
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Fountain Valley, California 92708
Principal Investigator: Haresh Jhangiani
Phone: 714-698-0300
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Fountain Valley, CA
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Freehold, New Jersey 07728
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Freehold, NJ
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Howell, New Jersey 07731
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Howell, NJ
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Lake Success, New York 11042
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Lake Success, NY
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Mount Holly, New Jersey 08060
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Mount Holly, NJ
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Mount Kisco, New York 10549
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Mount Kisco, NY
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Nashville, Tennessee 37203
Principal Investigator: Ian Flinn
Phone: 615-329-7274
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Nashville, TN
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Purchase, New York 10577
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Purchase, NY
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Principal Investigator: Joseph Mace
Phone: 727-216-1143
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Saint Petersburg, FL
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Somerville, New Jersey 08876
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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Somerville, NJ
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