Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Aug 30, 2022
  • participants needed
    64
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 30 June 2021
lymphoma
carbon monoxide
ejection fraction
measurable disease
doxorubicin
chemotherapy regimen
classical hodgkin lymphoma
refractory hodgkin lymphoma

Summary

The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.

Details
Condition Hodgkin's Disease, Lymphoma, Relapsed or Refractory Hodgkin Lymphoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment Gemcitabine, Pembrolizumab, Vinorelbine, Liposomal Doxorubicin, Stem cell mobilization and collection
Clinical Study IdentifierNCT03618550
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on30 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologic diagnosis of classical Hodgkin's lymphoma
Primary refractory or relapsed disease proven by excisional or core needle biopsy at enrolling institution
Relapse or refractory disease following 1 line of multi-agent chemotherapy
Be willing and able to provide written informed consent/assent for the trial
Be 18 years of age on day of signing informed consent
Have measurable disease based on Lugano 2014 criteria
Have a performance status of 0 or 1 on the ECOG Performance Scale
Demonstrate adequate organ function as defined in table below
Absolute neutrophil count (ANC) 1000 /mcL
Platelets 50,000 / mcL
Hemoglobin 8 g/dL
Serum creatinine OR 1.5 X upper limit of normal (ULN) OR
Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Serum total bilirubin 1.5 X ULN OR 3 X ULN for subjects with liver metastases
AST (SGOT) and ALT (SGPT) 2.5 X ULN OR 5 X ULN for subjects with liver metastases
Hemoglobin-adjusted diffusing capacity for carbon monoxide 50% (If unadjusted DLCO is >/= 50% then there is no need to calculate adjusted)
Ejection fraction 45%
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication
Female subjects of childbearing potential must be willing to use an adequate method of contraception
Male subjects of childbearing potential must agree to use an adequate method of contraception

Exclusion Criteria

Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma
Known pregnancy or breast-feeding
Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had an allogeneic hematopoietic transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD.)
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