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Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
Overall Recruitment Status: Enrollment not started
 
Official Title
A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
 
Region Sponsors
Northwest
National Cancer Institute (NCI)
 
Acronym KP IRB No.
1530706
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma, Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma, Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma, Ann Arbor Stage IIIA Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma, Ann Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma, Ann Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Lymphocyte-Rich Classic Hodgkin Lymphoma.
 
Purpose
This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back
 
Detailed Description
To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine). Patients are randomized to 1 of 2 arms: ARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 5-10 and 20-25 for adults or days 4-9 for pediatric patients. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. ARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 5-10 and 20-25 for adults or days 4-9 for pediatric patients. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. After completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • All patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible
  • Patients must have bidimensionally measurable disease (at least one lesion with longest diameter >/= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave
  • Patients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, magnetic resonance imaging [MRI] or MRI-PET is acceptable in event that PET-CT is contraindicated, however the same modality must be utilized through the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted
  • At registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator's intent-to-treat with residual PET RT. All patients enrolled by Children's Oncology Group (COG) investigators will be considered intent-to-treat with residual PET RT
  • Please contact study team for more eligibility criteria
 
Exclusion Criteria
  • Patients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted
  • Patients must not have had prior solid organ transplant
  • Patients must not have had prior allogeneic stem cell transplantation
  • Patients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load and no residual hepatic impairment are eligible
  • Patients must not have any known central nervous system lymphoma
  • Patients must not have a history of or active interstitial pneumonitis or interstitial lung disease
  • Patients must not have had a diagnosis of inherited or acquired immunodeficiency
  • Patients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (>/= 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses >/= 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Adjuvants, Immunologic
  • Lymphatic Diseases
  • Antibiotics, Antineoplastic
  • Lymphoma
  • Antibodies
  • Lymphoproliferative Disorders
  • Antibodies, Monoclonal
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents
  • Neoplasms
  • Antineoplastic Agents, Immunological
  • Neoplasms by Histologic Type
  • Dacarbazine
  • Nivolumab
  • Doxorubicin
  • Oncology (Pediatrics)
  • Enzyme Inhibitors
  • Pathologic Processes
  • Hodgkin Disease
  • Pathology
  • Imidazole
  • Physiological Effects of Drugs
  • Immune System Diseases
  • Sclerosis
  • Immunoglobulins
  • Topoisomerase II Inhibitors
  • Immunologic Factors
  • Topoisomerase Inhibitors
  • Immunoproliferative Disorders
  • Vinblastine
  • Lenograstim
  • Oncology (Adult)
  • Liposomal doxorubicin
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)
  • Oncology (Pediatrics)
  • Pathology


Principal Investigator:
Abdul Hai Mansoor, RN
Contact Information:
- Rhonda Stephenson, RN
-503-335-6310
-rhonda.stephenson@kpchr.org
-Central Interstate Medical Office


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