Phase
Condition
Lymphoma
Hematologic Cancer
White Cell Disorders
Treatment
Stem cell mobilization and collection
vinorelbine
pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologic diagnosis of classical Hodgkin's lymphoma.
Primary refractory or relapsed disease proven by excisional or core needle biopsy atenrolling 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 ofcreatinine or CrCl) ≥60 mL/min for subject with creatinine levels > 1.5 Xinstitutional 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 livermetastases
Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCOis >/= 50% then there is no need to calculate adjusted)
Ejection fraction ≥45%
Female subject of childbearing potential should have a negative urine or serumpregnancy within 72 hours prior to receiving the first dose of study medication.
Female subjects of childbearing potential must be willing to use an adequate methodof contraception
Male subjects of childbearing potential must agree to use an adequate method ofcontraception.
Exclusion
Exclusion Criteria:
Received more than 1 prior treatment (combined modality therapy represents 1treatment) for Hodgkin Lymphoma
Known pregnancy or breast-feeding.
Breast-feeding should be discontinued prior to treatment initiation.
Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of theattending physician and/or principal investigator, makes participation in this studyinappropriate.
Has received prior radiotherapy within 2 weeks of start of study treatment.Participants must have recovered from all radiation-related toxicities, not requirecorticosteroids, and not have had radiation pneumonitis.
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.
Has active autoimmune disease that has required systemic treatment in the past 2years (i.e. with use of disease modifying agents, corticosteroids orimmunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency, 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 thefirst dose of study drug. Administration of killed vaccines is allowed.
Has a history of (non-infectious) pneumonitis that required steroids or has currentpneumonitis.
Has an active infection requiring systemic therapy.
Has undergone solid organ transplant at any time, or prior allogeneic hematopoieticstem cell transplantation within the last 5 years. (Subjects who have had anallogeneic hematopoietic transplant greater than 5 years ago are eligible as long asthere are no symptoms of GVHD.)
Study Design
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering @ Rockville
Rockville Centre, New York 11570
United StatesSite Not Available
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United StatesActive - Recruiting
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