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

Last updated: December 13, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Hematologic Cancer

White Cell Disorders

Treatment

Stem cell mobilization and collection

vinorelbine

pembrolizumab

Clinical Study ID

NCT03618550
18-160
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 257
Treatment Group(s): 5
Primary Treatment: Stem cell mobilization and collection
Phase: 2
Study Start date:
August 01, 2018
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Commack

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering @ Rockville

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau

    Uniondale, New York 11553
    United States

    Active - Recruiting

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