PET-Directed Therapy With Pembrolizumab and Combination Chemotherapy in Treating Patients With Pr… (NCT03226249) | Clinical Trial Compass
UnknownPhase 2
PET-Directed Therapy With Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Classical Hodgkin Lymphoma
United States30 participantsStarted 2017-11-09
Plain-language summary
The purpose of this research study is to evaluate a new drug pembrolizumab in combination with chemotherapy, for the treatment of newly diagnosed Hodgkin lymphoma. The chemotherapy regimen is called AVD and includes three drugs: adriamycin, vinblastin, dacarbazine. Pembrolizumab is currently FDA approved for the treatment of some patients with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the treatment of Hodgkins Lymphoma. The AVD regimen of chemotherapy is currently FDA approved for the treatment of newly diagnosed Hodgkin lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. For patients who have a new diagnosis of Hodgkins Lymphoma, multi-agent chemotherapy is recommended. Also, for patients who do not have a complete response to chemotherapy (meaning there is still evidence of disease on PET scans performed at the end of treatment), radiation is sometimes recommended. Furthermore, the rare patient who relapses after chemotherapy requires treatment with high dose chemotherapy and a transplant.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of classical Hodgkin lymphoma including nodular sclerosis, mixed cellularity, lymphocytic-rich, and lymphocyte depleted subtypes by the 4th edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues published in 2008 (nodular lymphocyte-predominant Hodgkin lymphoma \[NLPHL\] excluded)
* Patients must have measurable disease by the Lugano criteria
* Patients must have previously untreated disease (except for one week or less of corticosteroids)
* Patients must exhibit a/an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patients may have any stage and any International Prognostic Score (IPS)
* Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined below:
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcl
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal (ULN)
* Creatinine within normal institutional limits
* Platelet transfusions are acceptable prior to treatment to achieve the above numbers, however growth factors are not allowed within 14 days of registration
* Females of child-bearing potential (FOCBP) and males must a…
What they're measuring
1
Complete Response (CR) With Pembrolizumab Treatment Alone
Timeframe: After 3 cycles of pembrolizumab (1 cycle = 21 days)