Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma

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Trial ID: NCT04788043

Purpose

The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma.

Official Title

A Phase 2 Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma

Stanford Investigator(s)

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Eligibility


Inclusion Criteria:

   - Age ≥ 18 years

   - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

   - Biopsy proven relapsed or refractory cHL

   - Prior treatment with at least two systemic therapies

   - Metabolically active measurable disease by PET imaging per the 2014 Lugano criteria

   - Hemoglobin ≥ 9.5 g/dL

   - Absolute neutrophil count ≥ 1,000 cells/μL without G-CSF support within 3 weeks prior
   to enrollment

   - Platelet count ≥ 75,000 cells/μL

   - Creatinine clearance > 40 mL/min per the Cockroft-Gault formula

   - Total bilirubin < 1.5 x upper limit of normal (ULN) (or < 3.0 x ULN and primarily
   unconjugated in subjects with a history of Gilbert's syndrome)

   - Negative urine or serum pregnancy test within 30 days of enrollment and within 72
   hours before the first administration of magrolimab for women of childbearing
   potential

   - Women of childbearing potential must be willing to use at least 1 highly effective
   method of contraception during the study and continue for 4 months after the last dose
   of magrolimab

   - Male subjects who are sexually active with a woman of childbearing potential and who
   have not had vasectomies must be willing to use a barrier method of contraception
   during the study and for 4 months after the last dose of magrolimab

   - Ability to understand and the willingness to sign the written IRB approved informed
   consent document

   - Must be willing and able to comply with the clinic visits and procedures outlined in
   the study protocol

Exclusion Criteria:

   - Prior treatment with a PD-1 inhibitor within 3 months prior to enrollment

   - Prior treatment with antibodies targeting CD47 or SIRPα2

   - Prior allogeneic hematopoietic cell transplantation

   - Systemic autoimmune disorder on chronic immunosuppression (defined as ≥ 10 mg of
   prednisone daily)

   - RBC transfusion dependence, defined as requiring more than 2 units of RBCs during the
   4-week period prior to screening

   - History of hemolytic anemia, autoimmune thrombocytopenia, or Evan's syndrome within
   the last 3 months

   - Second malignancy not in complete remission for at least 1 year, excluding fully
   resected non melanoma skin cancer or localized prostate cancer

   - Women who are pregnant or breast feeding

   - HIV or hepatitis B or C infection with active viral replication by PCR

   - Second malignancy not in complete remission for at least 1 year, excluding fully
   resected non-melanoma skin cancer or localized prostate cancer

   - Active cardiac disease including unstable angina, decompensated congestive heart
   failure, or severe uncontrolled conduction abnormalities

   - History of non-infectious pneumonitis requiring corticosteroids or current pneumonitis

   - Significant medical conditions, as assessed by the investigators and IND holder, that
   would substantially increase the risk benefit ratio of participating in the study

   - History of psychiatric illness or substance abuse likely to interfere with ability to
   comply with protocol requirements

   - Received a live or live attenuated vaccine within 30 days before the first dose of
   study intervention

   - Received any anti-cancer therapy within 2 weeks prior to the first dose of study
   intervention

Intervention(s):

drug: Magrolimab

drug: Pembrolizumab

procedure: PET/CT

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Austin Yeung
650-736-1908

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